Comparative Effectiveness Trial of Perioperative Telemonitoring for Functional Recovery and Symptoms
Phase: NA
Conditions: Digestive System Carcinoma, Genitourinary System Carcinoma, Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm
Sponsor: City of Hope Medical Center

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CITY OF HOPE NATIONAL MEDICAL CENTER 
1500 E. DUARTE ROAD 
DUARTE, CA 91010 
DEPARTMENT OF Population Sciences – Division of Nursing Research and Education 
TITLE:  Comparative Effectiveness Trial of Perioperative Telemonitoring for Functional 
Recovery and Symptoms 
 
CITY OF HOPE PROTOCOL NUMBER: 20370             PROTOCOL DATED: 09/14/2022 
 
DATE(S)/ OF AMENDMENT(S)/REVISION(S): 
 
Initial Approval 
Protocol dated 07/20/20 
Version 00 
Amendment 1 
Protocol dated 11/12/20 
 
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Amendment 2 
Protocol dated 02/05/21 
 
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Amendment 3 
Protocol dated 04/06/21 
 
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Amendment 4  
 
 
Protocol dated 04/06/21 (tp) 
 
 
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Amendment 5 at Continuation  
Protocol dated 04/06/21 (tp) 
 
 
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Amendment 6  
 
 
Protocol dated 03/14/22  
 
 
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Amendment 7  
 
 
Protocol dated 09/14/22  
 
 
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Amendment 8   
 
 
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Amendment 10  
 
 
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Amendment 11  
 
 
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Amendment 12 at Continuation  
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Amendment 15  
 
 
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SPONSOR/IND NUMBER:  
Patient-Centered Outcomes Research Institute (PCORI) 
DISEASE SITE: 
 
 
GI, GU, GYN 
STAGE (if applicable):  
 
NA 
MODALITY: 
 
 
Intervention 
PHASE/TYPE: 
 
 
Phase III/Randomized 
ClinicalTrials.gov identifier: 
NCT04596384 
 
PRINCIPAL INVESTIGATORS:  
Virginia Sun, PhD, RN 
 
COLLABORATING INVESTIGATORS: Yuman Fong, MD, Betty Ferrell, PhD, FAAN, Dan 
Raz, MD, Laleh Melstrom, MD, Thanh Dellinger, MD, 
Bertram Yuh, MD, Heather Player, MD, Hans 

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Schoellhammer, MD, Marta Jankowska, PhD, Calvin 
Tribby, Maria Pakhdikian, MA, Jiue-An (Jay) Yang, 
PhD, Sarah Alismail, PhD 
 
 
PARTICIPATING CLINICIANS:  
Jae Kim, MD, Loretta Erhunmwunsee, MD, Lily Lai, 
MD, Kurt Melstrom, MD, Andreas Kaiser, MD, Stephen 
Sentovich, MD, Gagandeep Singh, MD, Mustafa Raoof, 
MD, Clayton Lau, MD, Kevin Chan, MD, Jonathan 
Yamzon, MD, , Roger Satterthwaite, MD, Ernest Han, 
MD, Lorna Rodriguez, MD, Stephen Lee, MD, , Isaac 
Paz, MD, Lawrence Wagman, MD, Mark Hanna, MD, 
Mehdi Kebria, MD, Wei-Chien Lin, MD, Aziz Ahmad, 
MD, Yih-Dar Nien, MD, Maria de Leon, MD, Kristina 
Wittig, MD, Harold Huss, DO, Adrian Kohut, MD, 
Bradford Kim, MD, Thinzar Lwin, MD, Ali 
Zhumkhawala, MD 
 
PATIENT PARTNERS AND OTHER 
Linda Cota-Robles, Enrique Cota-Robles, Margaret     
STAKEHOLDERS   
 
 
Nolde, Scott Racusin 
(not obtaining consent): 
 
 
 
 
STUDY STATISTICIANS:  
 
Yi Xiao, MS, Joycelynne Palmer, PhD 
 
NON-PHYSICIAN CONSENTERS: 
Fernanda Perez, BS, Evelyn Leyva, BSN, RN, Randy 
Lee, MHA, Jacqueline Carranza, BS, , Rosemary Prieto, 
BSN, RN, Elizabeth Bustamante, BS, Jennifer Tee, 
BSN, RN, Maricela Haj, RN, Suzanne Graf, MSN, RN, 
AGCNS-BC, OCN, Maria Pakhdikian, MA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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• Scheduled for 
major 
abdominal/pelvic 
procedures for 
treatment of GI, 
GU, GYN 
malignancies
• English or 
Spanish-speaking
• 18 years and older
N=398 
(199 per arm)
*Study iPads 
available for patients 
with no engagement 
device
Remote Perioperative Telemonitoring
•
Actigraph accelerometer
•
TapCloud™ platform for symptom 
reporting
•
Standard surgical care
•
Feedback alert system
•
1 or more symptoms with score of 
4-10
•
Daily steps 1500 or less
•
RN telephone contact for 
assessment/triage/education
R
A
N
D
O
M
I
Z
E
Enhanced Usual Care
•
Actigraph accelerometer
•
TapCloud™ platform for symptom 
reporting
•
Standard surgical care
•
Instructions to use call lines/triage 
center to contact surgical team with 
issues
Assessments before 
discharge, day 7, day 
14, day 30, day 60, day 
90
B
A
S
E
L
I
N
E
A
S
S
E
S
S
M
E
N
T
S
U
R
G
E
R
Y
Study Schema
Outcomes
Daily steps, sleep, sedentary 
time, symptom severity, 
symptom interference with 
activity,  postop complications, 
readmissions

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Protocol Synopsis 
Protocol Title: 
Comparative Effectiveness Trial of Perioperative Telemonitoring for Functional 
Recovery and Symptoms 
Brief Protocol Title for the Lay Public (if applicable): 
NA 
Study Phase: 
Phase III Interventional 
Participating Sites: 
COH Duarte, COH South Pasadena, COH Antelope Valley, and COH Upland. 
Rationale for this Study: 
Patients experience a decrease in functional capacity following their surgery with an 
increase in symptoms, resulting in a dramatic decline in their quality of life (QOL). In 
addition to these challenges, patient’s postoperative care and recovery primarily takes 
place in home settings due to increasing pressures to reduce readmissions and earlier 
postoperative discharge by the health care systems. As a result, physical function can 
decline severely and symptoms can progress before the surgical team is notified.  
Objectives: 
The primary purpose of this study is to test the efficacy of remote perioperative 
telemonitoring for functional recovery and postoperative complications in 438 GI, GU, 
GYN cancer surgery patients (398 patients for main trial, 40 for focus groups), 
comparing remote perioperative telemonitoring and surgeon care only patients. 
Study Design: 
This is a prospective, randomized, mixed methods, comparative effectiveness trial (1:1 
randomization) of perioperative telemonitoring in cancer surgery (GI, GU, GYN). We 
plan to enroll 438  subjects (398 patients for the main trial, 40 for focus groups) over an 
approximate 40 months. This study will utilize the TapCloudTM application to conduct 
study procedures. Patients enrolled in the study will use the TapCloudTM application to 
capture subjective ePROs (symptoms). Patients will also be given an Actigraph GT9X 
Link, a research-grade accelerometer, to capture and report functional activity data (daily 
steps and sedentary time) throughout the duration of the study to the TapCloudTM 
application. The remote perioperative telemonitoring program consists of a real-time, 
alert/feedback system that will trigger alerts into the TapCloudTM application when pre-
determined thresholds are exceeded. Clinical RNs will respond by initiating contact using 
the TapCloudTM application’s secure messaging system, or telephone calls if 
unsuccessful, to assess, triage, manage, and resolve the issue. 
Endpoints: 
Primary: 

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Higher daily steps, lower postop complications 
Secondary: 
Sleep, sedentary time, symptom severity, symptom interference, readmissions 
Sample Size: 
438 Patients (398 patients for the main trial, 40 for focus groups) 
Estimated Duration of the Study 
40 months 
Summary of Subject Eligibility Criteria: 
Study eligibility criteria include:  
• Cancer patients scheduled to undergo major abdominal surgery for GI, GU, or GYN 
malignancies or presumed GI, GU, or GYN malignancies (as determined by 
surgeons);  
• Ability to read and understand English or Spanish, and 
• Age 18 years or older 
Investigational Product Dosage and Administration: 
NA 
Clinical Observations and Tests to be Performed: 
Diagnosis, tumor stage, neoadjuvant treatments, Charlson-Deyo co-morbidity index, time 
to adjuvant treatment, pre-op Zubrod/ECOG performance score, name of 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, preop objective 
functional measures (6-Minute Walking Test, Timed Up and Go, Short Physical 
Performance Battery.  
Statistical Considerations: 
Aim 1 - The Aim’s primary endpoint will be the percent change from preoperative 
baseline in daily step count during the first 2 weeks post-discharge from hospital 
(measured on Discharge Day, Day +7, and Day +14). To recognize that these data may 
be missing not at random (ie, due to adverse event, distress, or withdrawal of consent), 
the effect of study intervention on primary endpoint will be modeled jointly with early 
withdrawal from data collection of that endpoint. Within the joint model, the sub-model 
for the primary endpoint will use generalized linear mixed modeling (with treatment and 
covariates as fixed factors, patient ID as random factor), while the other sub-model will 
analyze time to early withdrawal (Aim 3’s primary endpoint) using proportional hazards 
regression. Similar joint modeling will be carried out for Aim 1’s secondary endpoints 
(change from baseline in sedentary time, general symptoms, disease-specific symptoms).  
Aim 2 - The Aim’s primary endpoint will be maximum Comprehensive Complications 
Index (CCI) during the 30 days post-discharge. Maximum CCI will be categorized as 
above vs below 15, and logistic regression will be used to evaluate the effect of study 
intervention. The Aim’s secondary endpoint, time to hospital readmission through 90 
days, will be subjected to survival analysis, handling any early withdrawal from study as 
a competing endpoint.  

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Aim 3 - Treatment will be evaluated for association with this Aim’s primary endpoint, 
time to early withdrawal, using proportional hazards regression.  This analysis will be 
generated as a sub-model of the joint modeling for Aim 1.  
Aim 4 - Qualitative data from open-ended exit surveys and focus groups will be analyzed 
using the conventional content analysis approach.73 For focus groups, participants can 
choose to attend by telephone, videoconferencing, or in-person. This approach is used to 
describe a phenomenon where existing theory or research literature is limited. Data  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 to derive codes, and sorted into themes based 
on links and relationship. Dr. Sun and Dr. Ferrell will conduct a final validation review of 
the codes/themes to ensure consistency and clarity across all qualitative data. Data 
discordantly coded will be discussed for refinement and consensus purposes with the 
SAC. 
Sponsor/Licensee: 
Patient-Centered Outcomes Research Institute 
Case Report Forms 
Not Applicable 

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Table of Contents 
 
SECTION .............................................................................................................................. PAGE 
1.0 
Goals and Objectives (Scientific Aims) ............................................................................ 10 
2.0 
Background ....................................................................................................................... 11 
2.1 
Introduction/Rationale for Development ............................................................. 11 
2.2  
Overview of Proposed Study ............................................................................... 12 
2.3  
Preclinical Studies ................................................................................................ 12 
2.4  
Human Studies ..................................................................................................... 12 
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 
Program Overview – Conceptual Framework ..................................................... 15 
5.2 
Planned Duration of Therapy ............................................................................... 21 
5.3 
Criteria for Removal from Treatment .................................................................. 21 
5.4 
Subject Follow-Up ............................................................................................... 21 
5.5 
Supportive Care, Other Concomitant Therapy, Prohibited Medications ............. 21 
5.6 
Additional Studies ................................................................................................ 22 
5.6.1 
Laboratory Studies .................................................................................. 22 

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5.7 
Definition of Dose-Limiting Toxicity (DLT) ...................................................... 22 
6.0 
Dose Delays/Modifications for Adverse Events ............................................................... 22 
7.0 
Data and Safety Monitoring, Unanticipated Problems and Adverse Event Reporting ..... 22 
7.1 
Data and Safety Monitoring ................................................................................. 22 
7.2 
Monitoring and Personnel Responsible for Monitoring ...................................... 22 
7.3 
Reporting of Unanticipated Problems and Adverse Events ................................. 22 
8.0 
Agent Information and Risks ............................................................................................ 23 
9.0 
Correlative/Special Studies ............................................................................................... 23 
10.0 
Study Calendar .................................................................................................................. 24 
11.0 
Endpoint Evaluation Criteria/Measurement of Effect ...................................................... 25 
11.1 
Response Criteria ................................................................................................. 25 
12.0 
Data Reporting/Protocol Deviations ................................................................................. 25 
12.1 
Data Reporting ..................................................................................................... 25 
12.1.1 Confidentiality and Storage of Records .................................................. 25 
12.1.2 Subject Consent Form ............................................................................. 25 
12.1.3 Data Collection Forms and Submission Schedule .................................. 25 
12.2 
Protocol Deviations .............................................................................................. 27 
12.2.1 Deviation Policy ..................................................................................... 27 
12.2.2 Reporting of Deviations .......................................................................... 28 
12.2.3 Resolving Disputes ................................................................................. 28 
13.0 
Statistical Considerations .................................................................................................. 28 
13.1 
Study Design ........................................................................................................ 28 
13.2 
Statistical Analysis Plan ....................................................................................... 28 
14.0 
Human Subject Issues ....................................................................................................... 31 
14.1 
Institutional Review Board .................................................................................. 31 
14.2 
Recruitment of Subjects ....................................................................................... 31 
14.3 
Advertisements .................................................................................................... 31 
14.4 
Study location and Performance Sites ................................................................. 31 
14.5 
Confidentiality ..................................................................................................... 31 
14.6 
Financial Obligations and Compensation ............................................................ 32 
14.7 
Informed Consent Processes ................................................................................ 32 
15.0 
References ......................................................................................................................... 32 
 

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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 effective treatment for cancer is surgery. By definition, surgical 
procedures are invasive; patients experience an abrupt decline in functional capacity after 
surgery. In addition to postoperative functional declines, 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 Postoperative recovery challenges are compounded 
by healthcare systems-related trends, including pressures to reduce readmissions and earlier 
postoperative discharge. As a result, the majority of postoperative care and recovery takes place 
at home. After hospital discharge, physical function can decline severely and symptoms can 
progress before the surgical team is notified.  
 
A promising approach to early identification of post-discharge complications is through 
remote, real-time perioperative telemonitoring of functional activity and patient-reported 
outcomes (PROs). The approach can identify patients at risk for post-discharge complications, 
treat symptoms/complications in a real-time fashion, and prevent readmissions. The overall 
purpose of this study is to conduct a multi-site, comparative effectiveness, randomized controlled 
trial of perioperative telemonitoring for functional recovery in 438English and Spanish-speaking 
cancer patients (398 for the main trial, 40 for the focus groups) scheduled to undergo major 
abdominal surgery (GI, GU, GYN). The program will be implemented at three geographically 
diverse sites in the Greater Los Angeles area, including one serving a low resource, 
socioeconomically-disadvantaged population. Accordingly, we propose the following specific 
aims: 
 
Aim 1: Compare the impact of remote perioperative telemonitoring care versus surgeon only 
perioperative care on clinically significant changes in functional recovery (accelerometer daily 
step count) and related secondary patient-centered outcomes (sleep, sedentary time, symptom 
severity, symptom interference with daily activities).  
Hypothesis: Remote perioperative telemonitoring improves functional recovery after major 
abdominal surgery.   
 
Aim 2: Compare the impact of remote perioperative telemonitoring care versus surgeon only 
perioperative care on postoperative complications (Comprehensive Complications Index – CCI) 
and related secondary surgical outcomes (hospital readmission).  
Hypothesis: Remote perioperative telemonitoring reduces postoperative complications in the 30 
days after major abdominal cancer surgery. 
 
Aim 3: Compare early withdrawal (dropout or loss of accelerometer device) between the 
comparators.  
Hypothesis: Remote perioperative telemonitoring does not excessively burden patients and 
families. 
 
Aim 4: Explore perioperative telemonitoring care-related experiences (acceptability, technology 
usability, uptake/integration) among patients, families, and surgeons/nurses through qualitative 
focus groups and open-ended exit surveys.   
 
Research Question: What are the various stakeholder’s perspectives on remote perioperative 
telemonitoring care? 

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2.0 
Background 
2.1 Introduction/Rationale for Development 
Surgical Oncology is Increasingly Focused on Quality, Value, and Patient-Centeredness. 
Surgeons and cancer centers are increasingly asked to provide evidence of the quality and value 
of their care. Historically, surgical outcomes are measured by disease- and systems-related 
parameters, such as length of hospital stay, morbidity, readmission rates, and mortality.16, 17 
While important, these measures do not accurately reflect the surgical care experience from a 
patient’s perspective. Patient-centered outcomes are increasingly being used in routine cancer 
care as quality and value indicators.17-19 However, these outcomes are not adequately understood 
and routinely integrated into surgical oncology.  
Cancer Surgery is Complex, and Post-Operative Functional Impairments and Symptom 
Burden Are Common. More than 45 million Americans undergo surgery each year.20 Greater 
than 60% of cancer patients undergo surgical interventions21, and surgical interventions account 
for the most cures after a cancer diagnosis.22 Patients who undergo cancer surgery experience 
functional deficits and symptoms that negatively affect their recovery activities.23 Post-op 
functional impairments are common, including inability to perform activities of daily living.24 
Postoperative physical function is predictive of complications such as thromboembolism, 
pneumonia, and sarcopenia, resulting in prolonged hospital stays and readmissions.2, 25-30 Fatigue 
and pain are common, occurs in 80% of patients, and persists one year after surgery.22, 31 Other 
common symptoms include sleep disturbance, anxiety, depression, and loss of appetite.1, 24  
Monitoring Postoperative Recovery from Cancer Surgery is Challenging after Discharge. 
Due to changes in healthcare and advances in surgical techniques, surgeons are asked to 
discharge patients earlier after surgery. Operations that were previously associated with 10-20 
day hospital stays are now outpatient or short-stay procedures. Postoperative complications that 
traditionally arise in the hospital are also developing in the community and at home. The current 
delivery model for post-discharge care is largely inefficient and not proactive.32 Home health 
nurses are often dispatched for unresolved acute problems. Patients may contact the hospital 
when acute problems arise, but are often unaware of when to contact their surgeons (RQ-3). This 
often requires hours or days to resolve, and is burdensome for patients, families, and the 
healthcare system. Delays in communicating critical conditions may escalate problems beyond 
outpatient care. In critical situations, emergency room visits within the same healthcare system 
or at a different institution occur, resulting in inefficient and fragmented care.  
The burden of postoperative hospital readmissions after major cancer surgery is high.33-35 
Depending on the tumor site, 90-day readmission rates for major cancer surgery range from 23-
43%.36 Published data suggest that 30- and 90-day readmission rates are 30% and 43% for 
cystectomy, and 22% and 35% for esophagectomy and pancreatectomy.36, 37 Hospital 
readmissions are burdensome, and result in higher 1-year mortality rates, and delays in timing 
and eligibility for adjuvant therapies.33 Predictors of readmissions are similar across different 
tumor sites, and include functional impairments, comorbid conditions, and postoperative 
complications.36, 38  
There are Critical Knowledge Gaps on the Impact of Patient-Centered Outcomes in 
Cancer Surgery. The impact of routine symptom monitoring is predominantly tested in 
chemotherapy settings.39,40 These findings suggest a positive effect on patient-provider 
communication41-44, detection of unrecognized problems40, 44-47, guiding clinical care46, 48-50, 
health outcomes50-54, and survival.9 Few studies are conducted in surgical oncology, and few 

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included assessments/support before surgery.29 Current evidence suggest that functional activity 
is correlated with surgical outcomes. Higher Fitbit step counts in elderly patients after cardiac 
surgery was correlated with early recovery, shorter hospital stay, and more discharge to home.27 
Other recent studies include real-time location systems to promote early mobilization after 
abdominal surgery55, Fitbit step counts during inpatient recovery from metastatic cancer surgery 
(predictive of risk for 30 and 60 day readmission)56, feasibility and validity of accelerometer-
based physical activity data for postoperative recovery57, and mobile application and web-based 
PROs after major GI and gynecologic surgery.8, 11  
 
Although these data are promising, critical knowledge gaps exist. First, the empirical 
evidence in combining subjective and objective real-time health-related data is lacking.32, 58 
Current ongoing trials, including those funded through PCORI, are designed to focus primarily 
on post-operative symptoms. Second, current and prior studies did not assess outcomes at 
baseline (before surgery). This is important because evidence suggests that preoperative 
functional activity and PROs can predict the trajectory of functional and symptom recovery after 
surgery.1 
 
Despite the documented evidence and commercial availability of patient digital engagement 
platforms, the question remains whether telemonitoring is equally as beneficial or more 
beneficial for patients and families as standard surgeon only care. Both comparators have 
demonstrated benefits. It is possible that telemonitoring could provide more proactive, real-time 
quality surgical care earlier in the treatment course, however, clinical trials have not yet 
compared telemonitoring surgical care with surgeon only care. In addition, despite the evidence 
on the benefits of telehealth in oncology care, there is a lack of consensus on how best to 
integrate this into surgical care. Both comparators in this study are available to patients now; 
however, there is a need to compare both models and generate a stronger evidence base for 
patient-centered surgical care to inform clinical practice and policies 
 
2.2  
Overview of Proposed Study 
This is a prospective, randomized, mixed methods, comparative effectiveness trial (1:1 
randomization) of perioperative telemonitoring in cancer surgery (GI, GU, GYN). 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 
 
The remote perioperative care model is based on evidence from our previous work and 
several other telemonitoring interventions, including Basch and colleagues’ electronic symptom 
assessment trial9, and Peterson and colleagues’ CYCORE trial lon mobile and sensor technology 
in head and neck cancer.69 Our previous research in major abdominal cancer surgery shows that 
the median number of steps before surgery was 6,562; this number decreased to 483 during 
hospitalization, and increased to only 2,483 in the first 2 weeks post-discharge (Figure 1). We 
observed a correlation between daily steps and risk for postoperative complications as measured 
by the Comprehensive Complications Index (CCI) (Figure 2). The median number of steps at 

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day 7 was 1,689 (19% of steps at baseline). This strongly correlated with CCI score (r=-0.64, 
p<0.05), where patients with fewer daily steps were at higher risk for postop complications. 
Adherence rate for wearing the pedometer device was 88%. Individual symptom scores for pain, 
fatigue, sleep, and appetite had the highest severity during week 1 post-discharge.  
 
Of the 160 monitoring encounters, 34% generated an alert. Most of the alerts were generated 
during the first week post-discharge. 72% of the telephone encounters triggered by an alert were 
for symptom management. The most commonly reported issue during the encounters was for 
pain. For acceptability, patients reported that the telemonitoring program was easy to use. 
Patients reported no difficulty in answering PROs, and the majority found that the length of time 
was just right for completing ePROs (95%) and using the pedometer (70%). About 25% of 
patients thought that the length of time for pedometer monitoring was too short (up to 2-4 weeks 
after discharge), and desired to use the program longer.15 
3.0 
Patient Eligibility 
3.1 Inclusion Criteria  
 
The study sample will consist of 398 patients (199 per group) across the enrollment sites. 
We will also enroll about 40 patients for 4 focus groups; this will yield a final total of 438 
participants overall. This sample size takes into account an anticipated 20% attrition. The 
attrition rate is based on our pilot and previous studies in GI and thoracic surgery. We expect to 
have complete evaluable data on 332 patients (166 per group) at 30 days post-discharge; the 332 
evaluable patients will provide sufficient power for the primary endpoints. Patient eligibility 
criteria include: 1) cancer patients scheduled to undergo major abdominal surgery for GI, GU, or 
GYN malignancies or presumed GI, GU, or GYN malignancies (as determined by surgeons); 2) 
age 18 years and older, and 3) ability to read and understand English or Spanish. 
 
 
Several approaches will be undertaken to maximize ethnic minority recruitment and 
retention. These include: 1) using bilingual (English and Spanish) team members; and 2) weekly 
team meetings to assess ethnic minority accrual status at all four participating sites. In addition, 
we will leverage expertise from City of Hope’s Center of Community Alliance for Research & 
Education (CCARE) and Division of Health Equities to develop 1) appropriate standard 
operating procedures (SOPs) on ethnic minority recruitment, and 2) appropriate recruitment 
materials (IRB approved brochures, flyers). 
 
Figure 2. Association between CCI 
and daily steps at post-op day 7 
Figure 1. Median daily steps measured before surgery (pre-op), 
during 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 trial is based on the NIH’s age criteria, which defines an adult as 
individuals 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 or electronic 
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. Efforts will be made to extend the 
accrual to a representative population.  
4.0 
Screening and Registration Procedures 
4.1 Screening Procedures 
All eligible patients who meet study inclusion criteria will be identified through the Department 
of Surgery and all solid tumor surgery outpatient clinics at all participating sites. 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. Research staff will also attend key clinics and 
meetings (ambulatory clinics, tumor boards) on a weekly basis to identify eligible participants.  
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 electronic signatures 
from each patient per standard practice. 

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. The 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. Research Nurses and CRAs will be bilingual (English 
and Spanish), to ensure that informed consent is conducted in a linguistically-appropriate 
fashion. If necessary (i.e. if potentials have left the clinic), a telephone/verbal informed consent 
will be obtained first in order to begin study in a timely manner. Signed informed consent will 
then be obtained for this study when participants are at COH, or emailed or mailed to them, or 
other elect and returned to COH when signed, or completed via other electronic applications (i.e. 
DocuSign). Documentation of informed consent will be maintained in the subject’s research 
chart and electronic health records.   
We will obtain the following information from the EHR to track characteristics of patients who 
are screened as eligible but declined participation. Age, gender, race/ethnicity data will be 
obtained from the EHR on patients that declined participation. No other PHIs will be collected 
for patients who declined participation. In addition, if declined patients are willing, reasons for 
decline will be obtained verbally.  
We will track and report ethnic minority retention weekly during standing research team 
meetings and reports. Reports will be generated weekly to show data on ethnic minority 
retention. Efforts will be made to improve retention if retention is low and/or problematic.  
4.3 Registration Requirements/Process 
The Research Nurses and CRAs will establish eligibility and consent before contacting the 
registrar at the time of enrollment. The registrar will enter the patient on a pre-established 
randomization log, and report the assignment to the Research Nurses and CRAs, who will then 
communicate the assignments to the participants in both study arms. Participants will complete 
baseline assessment following informed consent.  
4.4 Randomization and/or Dose Level Assignment  
Each patient will be randomly assigned to either the remote perioperative telemonitoring or 
surgeon only perioperative care arm, using a stratified and blocked randomization. Strata will be 
defined by diagnosis (GI, GU, GYN) and surgical technique (minimally-invasive versus open). 
Variable block sizes will be used to maintain approximate balance and pre-assignment masking. 
5.0 
Treatment Program 
5.1 Program Overview – Conceptual Framework 
The study design is based on Lenz and Pugh’s Theory of Unpleasant Symptoms67, 68, adapted 
for cancer surgery. The theory has three major components: 1) the symptom experience, 2) 
factors that influence the symptom experience, and 3) consequences of the symptom experience. 
Although symptoms can occur alone, cancer patients often experience multiple symptoms that 

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interact with each other. Important dimensions to the symptom experience include intensity, 
timing, level of distress, and quality.  
As depicted in Figure 3, physiologic, psychologic, and situational factors can influence the 
patient’s symptom experience. Physiologic factors include sociodemographic, disease, and 
surgical characteristics. Psychologic factors include a patient’s emotional reaction to the illness 
and treatment. Situational factors include aspects of the social and physical environment (i.e. 
access to care) that may affect the symptom experience. These factors interact with each other to 
influence the symptom experience. 
 
The consequence of the symptom experience is functional activity. Functional activity has a 
reciprocal relationship to the symptom experience and influencing factors. Symptoms may have 
a direct, inverse relationship with the number of daily steps. For example, postoperative pain 
may limit a patient’s ability to walk. Depression/anxiety may limit a patient’s willingness to 
walk.  
The proposed comparators include the following: Remote Perioperative Telemonitoring 
Care7-15, which will include: 1) objective assessment of functional activity using Actigraph 
GT9X Link accelerometer with comprehensive assessment of functional capacity to guide 
prehabilitation needs; 2) subjective ePROs (TapCloud™ digital engagement platform);  3) real-
time, RN-driven alert/feedback system based on pre-determined outcome thresholds (daily steps 
of ≤ 1500; 1+ symptoms rated moderate to severe intensity) and triggered based on patient input; 
and 4) standard post-surgical care. When thresholds are met, RNs will proactively initiate patient 
contact via TapCloud™ secure messaging followed by telephone calls to asses, triage, and 
manage. Telemonitoring begins before surgery, and continues after discharge. Surgeon Only 
Perioperative Care involves routine care by the surgeon/surgical team of functional 
declines/symptoms. Patients/families will meet with the surgeon at least once before surgery, 
have pre-anesthesia assessment for pre-op final evaluation, be managed daily during postop 
inpatient acute care, have first postop visit 1-4 weeks after discharge, with follow-up as needed 
thereafter. Patient contacts after discharge are primarily reactive through standard procedures, 

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including: 1) contacting the surgeon if symptoms become severe and physical function worsens; 
and 2) use of the hospital call line to report problems.  
Remote Perioperative Design and Content - The telemonitoring care includes three key 
components. The first component involves objective assessment of functional activity. Before 
surgery, we will complete comprehensive functional activity assessment, using three objective 
functional measures (6 Minute Walking Test, Timed Up and Go, and the Short Physical 
Performance Battery). These measures, collectively, assesses functional impairments, risk for 
falls, and lower extremity capacity. Participant’s home environment (number of stairs) will also 
be assessed. Participants will undergo personalized prehabilitation based on assessment findings. 
We have experience with perioperative physical interventions that begins before surgery.70 
 
 Throughout the study, we will use Actigraph GT9X Link (Actigraph Corp), a research-grade 
accelerometer, to capture data. The GT9X Link captures multiple activity-related data, including 
daily steps taken and sedentary time. It uses a solid state 3-axis accelerometer to capture and 
record data. The device continuously monitors activity trends; data can be stored for up to 180 
days on the device. It is water-proof with a battery life of 14 days, and weighs 14 grams. The 
device has a programmable LCD window that can be configured to display date/time and real-
time activity feedback. Actigraph is among the most widely used and extensively validated 
device for activity monitoring.71     
 
The second component involves subjective ePROs (symptoms). We will deploy the 
TapCloud™ application to capture P in real-time.  TapCloud™ is a HIPAA-compliant, multi-
faceted digital patient engagement system that remotely connects and conveys critical health 
information between patients and clinicians.  Patients use the application on a smart device 
(phone, tablet) or home computer to collect and track symptoms. TapCloud™ has been tested in 
oncology populations, including surgical populations. A recent quality improvement project on 
rural palliative care established feasibility in technology literacy with participants (N=101) who 
lived in rural North Carolina; more than 50% of participants were 65 years and older.72  
 
All patient data captured via TapCloud™ application (PROs, Actigraph) will be streamed to 
a clinical dashboard that provides a consolidated view accessible from any device via an internet 
connection. The dashboard provides a graphic visualization over time of all patients, their 
accelerometer activity data, and symptoms. It is designed to facilitate outcome pattern and 
trends, including onset, worsening/improving measures, and sporadic vs. consistent measures. 
 
The third component involves a real-time, alert/feedback system based on pre-determined 
outcome thresholds. Alerts are triggered in real-time based on patient input into the TapCloud™ 
application. Pre-determined thresholds include: 1) daily steps of ≤ 1500; or 2) one or more 
symptoms rated 4 or greater (moderate-severe intensity). When thresholds are met, trained clinical 
RNs will receive secure alerts via the TapCloud™ application. The clinical RNs will initiate 
contact with patients via secure messaging through the application as a first attempt to assess and 
remedy the problem. If unsuccessful, telephone calls will be used to further assess, triage, 
manage, and resolve the issue. Figure 4 provides a graphic depiction of the telemonitoring care 
design. All participants will also receive standard surgical care.  

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Surgeon Only Perioperative Care - The “standard perioperative care” includes 
surgeon/surgical team management of functional declines/symptoms. Patients/families will meet 
with the surgeon at least once prior to surgery, have pre-anesthesia clinic visit for pre-op final 
evaluation, be managed daily during postop inpatient acute care, have first postop visit 1-4 weeks 
after discharge, with follow-up as needed thereafter. Patients may or may not undergo 
prehabilitation as this is not the current standard of care for the participating sites. Referral for 
functional and nutritional prehabilitation are at the discretion of the surgeon/surgical team. There 
are no scheduled contacts with the patient between discharge and 1-4 weeks after. 
Patients/families are instructed to follow the standard procedures for reporting problems between 
clinic visits, including: 1) contacting their surgical team if symptoms become severe and physical 
function worsens; and 2) use of the hospital call line to report problems. 
 
Study Procedures  
 
Following informed consent, a brief, 1-item health literacy screen (Screening Question for 
Limited Health Literacy) will be completed. Research staff will provide additional support 
(written instructions, telephone calls) for patients with limited health literacy. The 
Accrual/Evaluation RNs will engage patients in understanding the type and method of data 
collected, and how the data will be used to support decisions on personalized perioperative care.  
 
The Research staff will then address technology capacity and needs. This assessment 
includes 1) whether the patient has an engagement device and/or WiFi connection, 2) whether 
the patient lives in rural communities (as defined by the US Rural-Urban Commuting Area 
Codes – RUCA), and 3) technology literacy (comfort in using mobile applications and 
Patient
RN/Surgical Team
Alert/Feedback 
System
Cloud-Based 
Data Storage
Clinical Dashboard
PGHD & ePROs
Pre-Determined 
Thresholds
Figure 4. Perioperative Telemonitoring Care 

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smartphone/tablet/computers/laptops). The team will assist patients with identifying a patient-
owned engagement device (smartphone, tablet, computer), and assist with setup and initial 
testing of TapCloud™ application on selected device. If the patient does not have an engagement 
device, a study iPad will be loaned out to the patient along with an iPad loaner agreement. A 
mobile hotspot device will also be loaned out to the patient if they do not have internet access at 
home.The team will directly engage the patient (vs simply providing an instruction sheet) and 
will walk the patient through the setup in a step-by-step fashion. The patient will also be given a 
TapCloud™ instruction document. Setup will include downloading the application and testing 
the system to assure the application functions properly. Setup procedures also include a second 
test call to re-test the engagement device and mobile application, if needed. 
 
All patients will be provided with Actigraph GT9X Link (Actigraph Corp), a research-grade 
accelerometer and instructions on using the device. The Research staff will setup the device for 
patients and conduct initial testing to insure successful data transmission. For patients who do 
not have a device and wish to participate, an iPad with TapCloud platform already downloaded 
and ready for use will be provided for the duration of the study. Actigraphs and study iPads 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. 
 
We will assess technology uptake by quantifying 1) the type of digital engagement device 
selected for use by participants (smartphone, tablets, laptop); 2) number of participants who used 
a study iPad or mobile hotspot; and 3) all technological issues. This data will be documented by 
the team into the REDCap database, and monitored throughout the study period. The team will 
specifically monitor for any disproportionate technology uptake challenges by race/ethnicity and 
rurality. 
 
Patients will complete patient reported outcomes and objective assessments of functional 
activity before surgery. Patients will then be randomized to either the remote perioperative 
telemonitoring care group or surgeon only perioperative care group. 
 
Following surgery and before discharge, patients will complete patient reported outcomes. 
Patients will complete patient reported outcomes day 7, 14, 30, 60, and 90 post-discharge from 
hospital. On day 90 post-discharge, patients will participate in a brief open-ended exit surveys.  
 
Patients will be provided a patient packet, which includes a research team contact list, patient 
calendar, and Activity Monitor Tracking Sheet. The patient calendar will provide key dates for 
patient assessments, while the Activity Monitor Tracking Sheet will track specific times when 
the Actigraph is not worn and patient sleeping hours. An informational brochure containing key 
information about this study will also be given to patient in the enrollment process.  
 
Focus Group - In months 18-30 (Years 2-3) of the project, we will conduct 5 (4 for 
patients/families, 1 for surgeons/nurses) qualitative focus groups to understand  the perioperative 
telemonitoring  experiences from the  patients, families, and surgeons/nurses perspectives. Focus 
groups are a form of focused interview67 with the goal of examining an experience that 
respondents all have had and can speak about. The advantages of focus groups are 1) the group 
production of data and, 2) data-collection efficiency. Participants are often reassured to hear 
similar experiences on the part of others, and feel empowered to talk about their own ideas.84 The 
patient focus groups will solicit overall perioperative care experiences, while the open-ended exit 
surveys will focus specifically on the perioperative telemonitoring acceptability. A total of four 
focus groups will be conducted with patients/families. Two will include English-speaking 

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patients, with one focusing on older adults (65 or older), and one on younger adults (65 or 
younger). Both groups will enroll a total of 6-9 participants with equal representation by cancer 
type (GI, GU, GYN). The two focus groups for Spanish-speaking patients will follow the same 
pattern. Equal representation by cancer type will be used for the one surgeon/nurse focus group. 
 
Potential patient/family focus group participants will be drawn at random. Patients/families 
will be invited to participate; our consent form will have already alerted them that they may be 
asked to participate in a focus group study. If a patient declines participation in the focus group, 
families may still be approached if permitted, as the focus group questions for family caregivers 
will be focused on perioperative caregiving needs/caregiver support and not on the care of the 
patient. Surgeon focus group participants will be drawn from all surgeons/nurses who had at 
least one patient who participated in the study. Nurses will be drawn from those who monitored 
patients in the perioperative telemonitoring arm. A general rule of thumb is that focus groups 
work best with between 6-10 participants. However, it is frequently the case that not everybody 
who is invited participates84; therefore, we will invite 10 participants to each focus group. We 
anticipate about 6-9 participants for each group. For ease of participation, focus groups will be 
conducted via MS Teamsvideoconferencing; participants can also join by calling the telephone 
number for the Teams meeting. Patients/families selected to participate in the focus group will be 
offered $50 compensation for participation. 
 
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.  Functional activity - daily steps of ≤ 1500. 
 
2. Patient-Reported Outcomes:  
 
a.  One or more symptoms rated moderate-severe intensity 
Pathway for RN Triage and Management 
1.  Patient’s functional activity will be recorded throughout the study while wearing the 
accelerometer, and will complete patient reported outcomes before surgery, before discharge, 
and day 7, 14, 30, 60, and 90 post-discharge. 
2.  If RN identifies deviations from a priori thresholds, they will: 
i. 
Attempt to initiate contact with patients via secure messaging through the 
TapCloudTM application to assess and remedy the problem.  
ii. 
If unsuccessful, telephone calls will be used to further assess, triage, manage and 
resolve the issue. 
RN Training - In order to ensure consistency and establish fidelity, study RNs will attend a 1-
week training during month 2 of the project.  The training goals are: (a) to provide uniform 
telemonitoring and engagement of participants across all sites, (b) to plan for consistent 
procedures for participant engagement. The training will begin with the PI and surgeon co-
investigators providing an overview of the telemonitoring program via two full-day seminars. 
Following the seminars, mock sessions with patient/family stakeholders and surgeons will be 
completed by each RN. Feedback will be provided on performance, and additional training 
provided as needed. Training curriculum will be established for future use with other institutions. 

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Stakeholder Advisor Council and Stakeholder Panel - The project will be guided by a 
Stakeholder Advisory Council (SAC). Members will consist of the following: 3 patients, 1 
family caregiver, 4 surgical oncologists, and a digital patient engagement expert. In the first 3 
months of the study, all members of the SAC will meet on a weekly basis as part of the research 
team. The SAC will meet via videoconferencing with the PI, co-investigators, and study support 
staff (RNs, CRAs). In this study start-up phase, the SAC/investigators will review and refine 
study materials and protocols to ensure feasibility for patients, families, nurses, and surgeons. 
This will facilitate co-learning by establishing parameters and expectations for all roles and 
responsibilities. It will also allow the SAC members to immerse in the research process, and for 
the PI/co-investigators and research support staff to learn about patient-centeredness. During 
study accrual and implementation, the stakeholders will meet on a bi-weekly basis via 
videoconferencing; their input will be expected to inform the team of problems and possible 
solutions. We opted for the SAC to meet on a bi-weekly basis in order to accommodate their 
practical needs and availability. We believe this would not cause undue burden on our patient 
stakeholders and would average a 2-3 hours per month interaction as part of the research team. 
The SAC will have shared roles in research to identify any potential oversight, offer suggestions, 
and identify other concerns with study accrual and implementation. The SAC will be partners in 
decision-making, and will have the authority to make decisions equally with the PI and co-
investigators (Reciprocal Relationships). While the PI will lead team meetings, this will be an 
open forum for all team members. 
 
In addition to the core SAC, we will form a Stakeholder Panel of patients/families who have 
participated in the project. We will invite three patients/families who were participants and 
completed the study. The Panel will meet on a quarterly basis to provide feedback on their 
experience, review study implementation procedures, and provide input on implementation 
problems. New panel members will be recruited for each quarterly meeting. Each Stakeholder 
Panel member will be compensated for $100/hour. 
5.2 Planned Duration of Therapy 
Study participation is planned for approximately 3-4 months. The timeframe covers 
before surgery, postop acute care, and 90 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 3-4 months. 
5.5 Supportive Care, Other Concomitant Therapy, Prohibited Medications 
The 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 

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no restrictions to the use of supportive care medications, other concomitant therapy and no 
prohibited medications.  
 
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 Risk Level 1 study, as defined in the City of Hope Institutional Data and Safety 
Monitoring Plan [policy effective date:  07/09/14], because it involves questionnaires assessing 
symptom severity and daily steps using wearable accelerometers. 
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 
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. 
 

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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 
Agent Information and Risks 
Not applicable. 
9.0 
Correlative/Special Studies 
No correlative studies will be performed during this study.

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10.0 Study Calendar 
 
 
Table 4. Outcome Measures by Aims and Assessment Time Points 
 
Measures 
Before 
Surgery (T1) Pre-Discharge (T2) 
Day 7 
(T3) 
Day 14 
(T4) 
Day 30 
(T5) 
Day 60 
(T6) 
Day 90 
(T7) 
Preop 
Functional 
Assessment 
6 Minute Walking Time (6MWT) 
X 
 
 
 
 
 
 
Timed Up and Go (TUG) 
X 
 
 
 
 
 
 
Short Physical Performance Battery (SPPB) 
X 
 
 
 
 
 
 
Aim 1 
 
Functional Recovery (steps taken, sedentary 
time)  
X 
X 
 
X 
 
X 
 
X 
 
X 
X 
General Symptoms - MD Anderson Symptom 
Inventory (MDASI) 
X 
X 
X 
X 
X 
X 
X 
Aim 2 
 
Post-Operative Complications – CCI 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
Hospital Readmissions 
 
 
X 
X 
X 
X 
X 
Aim 3 
Early withdrawal (dropout, loss of device) 
Throughout the Study 
Aim 4 
Open-Ended Patient Exit Survey 
 
 
 
 
 
 
X 
Patients/Families/Surgeon/Nurses Experience – 
Focus Groups 
Year 2-3, Month 22-30 

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11.0 Endpoint Evaluation Criteria/Measurement of Effect 
11.1 Response Criteria  
Not applicable. 
12.0 Data Reporting/Protocol Deviations 
12.1 Data Reporting 
12.1.1 Confidentiality and Storage of Records 
A REDCap database will be developed with support from COH’s Research Informatics team for 
this study. All outcomes will stored electronically in the REDCap database. The database is 
passcode-protected, and only the PIs and research staff will have access to the REDCap database.   
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. 
12.1.2 Subject Consent Form 
Initial verbal consenting will only be used when potential participants are not in the clinic. In 
these situations, the Research Nurses and CRAs will use the approved information sheet for 
verbal consent process. An informed consent will then be obtained either in writing in person, by 
mail, or electronic mail, or electronically via other electronic applications (i.e. DocuSign). 
Otherwise, all participants will complete written or electronic informed consent (i.e. DocuSign) 
informed consent prior to study participation. The study will use one written or electronic 
informed consent (with signature line) and one information sheet (without signature line) for 
patients.  Documentation of initial verbal consent for study participation will be charted through 
progress notes and maintained in the patients’ electronic medical records as required by the 
Institutional Review Board.  
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 wearable devices (accelerometer) and electronic PROs. Data will 
be sent to the location identified in Section 12.1.1 and stored in a secure location. 
Preoperative Functional Assessments – For prehabilitation needs (referrals to PT/OT), we will 
use the following: 6-Minute Walking Test (6MWT) – This is a performance-based, 15 minute 
measure of functional exercise capacity.77-79 It measures the distance that an individual is able to 
walk over a total of six minutes on a hard, flat surface. Patients are allowed to self-pace and rest 
as needed. Timed Up & Go (TUG) - This is a test of physical mobility. The test, measured in 

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seconds, is the time it takes for an individual to stand up from a standard arm-chair (approximate 
seat height of 46 cm), walk a distance of 3 meters (10 feet), turn, walk back to the chair, and sit 
down again.80 Short Physical Performance Battery (SPPB) - This is a tool designed to 
quantify physical performance and decline over time. The test focuses primarily on lower 
extremity function and includes a 4 meter walk to measure gait speed, one chair stand (followed 
by 5 timed chair stands, if the first is successfully completed), and balance stands with the feel 
held in different positions for 10 seconds each. The test takes about 10 minutes to complete.81, 82 
 
Health literacy screen – A brief 1-item screening will be performed following informed consent 
to screen for limited health literacy.  
 
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. 
General Well-Being – this will be assessed using one question: Compared to yesterday, how do 
you feel (worse, same, better).  
MD Anderson Symptom Inventory (MDASI) - The MDASI is a validated measure of 13 
common cancer-related symptoms: pain, fatigue, nausea, sleep, distress/anxiety, shortness of 
breath, memory, appetite, dry mouth, drowsiness, sadness, vomiting, and numbness/tingling. 
Each symptom’s severity is rated on a 10-point scale. A score of 1-3 indicates mild intensity, and 
4-10 moderate to severe intensity. Patients also rate how much their symptoms interfered with 6 
common functional domains: walking, activity, working/housework, social relationships, 
enjoyment of life, and mood. A movement of 1.2 points is clinically meaningful. The MDASI 
has been validated in surgical populations; Cronbach Alpha reliability ranges from 0.82 to 
0.94.46, 83 
Functional Activity (Actigraph) – Based on published recommendations on best practice in use 
of accelerometry84-87, we will initiate several parameters to ensure that the data captured is 
reliable. First, data will be collected in 1 second epochs and reintegrated to 60 second epochs for 
analysis. Non‐wear time will be defined as 60 minutes of continuous 0 counts. A minimum of 4 
weekdays and 1 weekend day with at least 600 minutes (10 hours) of daily wear time will be 
considered valid. In order to be considered a valid day, patients need to wear the accelerometer 
for at least 10 waking hours (600 minutes). Data capture will focus on the following: 1) number 
of steps taken per day and 2) sedentary time. Recommended activity counts per minute (cpm) 
cutpoints will be used to categorize sedentary time (<100 cpm) from light‐intensity physical 
activity (100–1951 cpm) and moderate/vigorous intensity physical activity (≥1952 cpm). 
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.88, 89  
Readmissions - Electronic health record audits will capture: 1) 30, 60, and 90 day inpatient 
readmissions, 2) reasons for readmissions, and 3) ER visits. 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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Focus Group Guides - The semi-structured questions for focus groups are designed to solicit 
patient/families and surgeon/nurse perspectives on the following: 1) overall perceptions of 
perioperative care; 2) unmet needs during pre-and postoperative care; 3) greatest challenges 
before and after surgery; 4) postoperative recovery process at home; 4) use of telemonitoring 
application for communication (surgeon/nurses); 5) use of telemonitoring dashboard to guide 
clinical care (surgeon/nurses).  
 
Exit Surveys – This survey contains several open-ended questions that participants in the 
perioperative telemonitoring arm will complete. The participants will provide information via 
written comments. The questions are designed to solicit feedback on the following: 1) on-
boarding and setup process; 2) use and setup process of accelerometer; 3) value of monitoring 
PROs and functional activity;; 4) satisfaction with the timing of the telemonitoring (starts before 
surgery and continues up to 3 months after discharge from hospital); 5) satisfaction with the 
methods/technology used (mobile application, wristband watch) 6) most useful components of 
the telemonitoring for helping with postoperative recovery; 7) likes/dislikes of the program; 8) 
challenges and limitations of telemonitoring; and 9) suggestions on areas for improvement.  
 
12.1.3.1 Eligibility Checklist 
No eligibility checklist will be used in this study as the eligibility criteria is short.  
12.1.3.2 Prior Therapy Forms and On-Study Forms 
No prior therapy forms and on-study forms will be used in this study.  
 
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. 

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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 
The COH Investigational Drug Service (IDS) cannot release a research agent that would cause a 
protocol deviation without approval by the PI.  Whenever the protocol is ambiguous on a key 
point, the IDS should rely on the PI to clarify the issue. 
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. 
 
13.0 
Statistical Considerations 
13.1 Study Design 
This is a prospective, randomized, mixed methods, comparative effectiveness trial (1:1 
randomization) of perioperative telemonitoring in cancer surgery (GI, GU, GYN). These cancer 
sites were selected because the surgical procedures, extent of resection, and expected surgical 
outcomes are similar. Our CER question is: What are the comparative effectiveness of remote 
perioperative telemonitoring care as compared to the surgeon (and surgical team) only 
perioperative care? This research focuses on comparing the two groups to identify which 
approach will most benefit cancer surgery patients. 
 
In Aim 1, clinically significant changes in functional recovery (accelerometer daily step 
count) and related secondary patient-centered outcomes (sleep, sedentary time, symptoms, 
symptom interference with activity) will be tested over time by the comparators (remote 
perioperative telemonitoring care versus surgeon only perioperative care). The primary 
outcome is the clinically significant change in accelerometer daily step count over time. In Aim 
2, we will test changes in postoperative complications and related secondary surgical outcomes 
(hospital readmissions) by the comparators. Here, the primary outcome is postoperative 
complications in the 30 days after surgery. In Aim 3, we will compare early withdrawal (dropout, 
loss of device) between the comparators. Finally, in Aim 4, we will qualitatively explore the 
perioperative telemonitoring experience from the patients, families, and surgeon’s/nurse’s 
perspective. This aim was included to explore perioperative care-related experiences 
(acceptability, technology usability, uptake/integration) among patients, families, and 
surgeons/nurses through qualitative focus groups and open-ended exit surveys. The data will be 
used to refine and assure model fidelity in future studies. It will also guide future integration into 
other healthcare system settings.  
13.2 Statistical Analysis Plan 
Data Management - We expect a total of 12 symptom evaluations per participant over the 3-4 
month study duration. With a total sample of 332, this yields approximately 4,000 data collection 
encounters overall. We expect a large number of daily steps data observations per subject, as 
functional recovery data will be continuously recorded on a daily basis over the study duration.  

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Data will be transferred in real-time (within 2 minutes of participant completion) from 
TapCloud™ to a REDCap (Research Electronic Data Capture) study database. Daily step count 
will be continuously transferred to the study database in real-time. The database resides in secure 
COH research networks for research team access only. An assigned master’s-level Statistical 
Research Associate (SRA) with paid effort on the project will be responsible for coordinating 
monthly data transfer, auditing, and data cleaning. In the process of data transfer and mergers, 
the study biostatistician (Dr. Behrendt), SRA, and TapCloud™ representative will audit and 
clean the data, apply formats in statistical software, and export data into REDCap database.  
Handling Missing Data and Lost to Follow-Up  - We will integrate the following strategies to 
prevent, detect, and remedy missing data in real time. First, participants will receive a total 
remuneration of $50 for providing data. Second, research staff will provide telephone/email 
reminders before each of the scheduled data collection timepoints to maximize adherence. 
Regular contact will also be provided to remind participants to wear the accelerometer. Third, 
research staff will provide each participant with a simple study calendar with data collection 
dates.  Fourth, if no data is completed by participants, research staff will contact the participant 
in real-time to engage and assess. The Statistical Methods section below describes how data 
missing not at random will be handled in the analyses. 
Preliminary Analysis - Descriptive statistics will be used to summarize all variables.  
Characteristics of participants at baseline will be reported in tabular form using appropriate 
descriptive statistics. Prior to hypothesis testing, the relationship between demographic variables 
and primary outcome variables (daily step count, postop complications) will be examined. 
Significant relationships/correlations will guide the addition of demographic variables to the 
analysis.  
Heterogeneity of Treatment Effect - Exploratory use of interaction terms will assess whether 
significant effects of the study intervention differ by sex or by age (i.e., above vs below 70 
years). If found to be present, any such heterogeneity of treatment effect, not having been 
hypothesized in advance, will be reported as a preliminary finding that awaits confirmation in 
future studies. 
Internal/External Validity and Avoidance of Bias - To limit possible confounding of the 
primary results, analyses of the prespecified hypotheses will be adjusted for covariates (age, sex, 
physical fitness at pre-surgical baseline). To assess the representativeness of study participants, 
their demographic characteristics (sex, age) will be compared to those of eligible patients who 
are approached for consent but decline to participate in the study. Our digital engagement 
platform will initiate reminder systems to reduce loss to follow-up. 
Statistical Methods by Study Aims - Characteristics considered as potential covariates in all 
analyses will be age, sex, surgical technique, residential setting, and physical fitness at 
preoperative baseline. Any covariate that improves the model’s fit to the observed data will be 
retained in the final analysis. 
 
The analyses for Aims 1-3 will be by intention to treat (ITT); the ITT population will include all 
subjects who have given informed consent, been randomized to intervention or control arm, and 
undergone the planned cancer surgery. 
 
Aim 1 – Allowing for an anticipated 20% attrition in use of accelerometer by Day 14 across both 
trial arms, an initial sample size of 332 (randomized 1:1) will provide (per East 6.5 software) 

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80% power to detect the hypothesized 14% difference in slope due to study intervention, using a 
1-sided, repeated measures-difference of slope test with alpha=0.025. 
 
The Aim’s primary endpoint will be the percent change from preoperative baseline in daily step 
count during the first 2 weeks post-discharge from hospital (measured on Discharge Day, Day 
+7, and Day +14). percent change from preoperative baseline in daily step count during the first 
2 weeks post-discharge from hospital (measured on Discharge Day, Day +7, and Day +14). To 
recognize that these data may be missing not at random (ie, due to adverse event, distress, or 
withdrawal of consent), the effect of study intervention on primary endpoint will be modeled 
jointly with early withdrawal from data collection of that endpoint. Within the joint model, the 
sub-model for the primary endpoint will use generalized linear mixed modeling (with treatment 
and covariates as fixed factors, patient ID as random factor), while the other sub-model will 
analyze time to early withdrawal (Aim 3’s primary endpoint) using proportional hazards 
regression. Similar joint modeling will be carried out for Aim 1’s secondary endpoints (change 
from baseline in sedentary time, general symptoms, disease-specific symptoms). 
  
Aim 2 – Because the CCI is derived from data routinely entered in the medical chart, no loss to 
follow-up is anticipated for this endpoint. A sample size of 332 subjects randomized 1:1 will 
provide (per East 6.5 software) 88% power to detect the hypothesized CCI benefit, using a 1-
sided test of proportions, unpooled estimate of variance, critical p-value for efficacy=0.024, 
cumulative alpha=0.025.  
 
The Aim’s primary endpoint will be maximum Comprehensive Complications Index (CCI) 
during the 30 days post-discharge. Maximum CCI will be categorized as above vs below 15, and 
logistic regression will be used to evaluate the effect of study intervention. The Aim’s secondary 
endpoint, time to hospital readmission through 90 days, will be subjected to survival analysis, 
handling any early withdrawal from study as a competing endpoint.  
 
Aim 3 - The trial’s sample size of n=332 will provide (per SAS software, PROC POWER for 
two-sample comparison of proportions) at least 80% power.  
 
Treatment will be evaluated for association with this Aim’s primary endpoint, time to early 
withdrawal, using proportional hazards regression.  This analysis will be generated as a sub-
model of the joint modeling for Aim 1.  
 
Aim 4 - Qualitative data from exit interviews and focus groups will be analyzed using the 
conventional content analysis approach.73 Written survey comments will be transferred to, and 
data from the audio-recorded focus groups 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 to 
derive codes, and sorted into themes based on links and relationship. Dr. Sun and Dr. Ferrell will 
conduct a final validation review of the codes/themes to ensure consistency and clarity across all 
qualitative data. Data discordantly coded will be discussed for refinement and consensus 
purposes with the SAC. 
 
The team will use a mixed methods approach to enhance interpretation of study findings. For 
interpretation of study findings, the exit survey and focus group data will be used to augment 
quantitative data in Aims 1-3 (perioperative experience with functional recovery, symptoms, 

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sedentary time, postoperative complications, hospital readmissions, burden of telemonitoring). 
One approach to qualitative analysis is to use the quantitative outcomes of interest as themes for 
coding the qualitative data. Therefore, each quantitative outcome of interest will have 
corresponding qualitative data in the participants and stakeholder’s own words. The table below 
illustrates the connection between quantitative and qualitative data. 
Quantitative Outcomes 
Connections with Qualitative Data 
Functional recovery/sedentary time 
Patient/family partner focus groups – overall 
experience with postop functional 
recovery/sedentary time 
Sleep, symptom severity, symptom 
interference with daily activities 
Patient/family partner focus groups – overall 
experience with postop symptoms 
Postoperative complications (Comprehensive 
Complications Index – CCI) and related 
secondary surgical outcomes (hospital 
readmission).  
Surgeon-nurses focus groups 
Patient/family partner focus groups – overall 
experience  
Early withdrawal (dropout or loss of 
accelerometer device)  
Telemonitoring arm open-ended exit survey 
 
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 Duarte, South Pasadena, Antelope Valley, and Upland 
sites 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 three geographically diverse sites in the Greater Los 
Angeles area, including City of Hope at Duarte, South Pasadena,  Antelope Valley, and Upland. 
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 

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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 
 
Participants will not incur any financial obligations. Participants will be compensated $25 
after completion of day 60 and day 90 assessments, for a total of $50. Patients/families selected 
to participate in the focus group will be offered $50 compensation for participation. Each SAC 
member will be compensated at $25/hour for an estimated 100 hours/year (total of $2500/year). 
Each Stakeholder Panel member will be compensated for $100/hour. 
14.7 Informed Consent Processes  
The Research Nurses and CRAs will contact eligible participants and explain the study 
purpose, answer questions, and ascertain interest in participation. The primary approach for 
informed consent will be during an in-person encounter. Obtaining a signature of the consent 
form by the patient/caregiver may also be completed by sending the consent form by mail or 
electronic mail, and returned to City of Hope, or electronically via other electronic applications 
(i.e. DocuSign). Research team members will be bilingual (English and Spanish). We will only 
use telephone verbal consents in situations where patients are not returning to COH prior to 
surgery date. If, during, the first phone call, participants are willing to consent for enrollment, the 
Research Nurses and CRAs will proceed with verbal consent. The Research Nurse and CRAs 
will document the provision of verbal consent via progress note as required by IRB policies.  
 
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. 
 
 
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