Does Increased Mobility Assessed With 3D Motion Tracking Technology Lead to Early Post-Operative Recovery Among Patients Undergoing Oncologic Surgeries
Phase: NA
Conditions: Malignant Neoplasm
Sponsor: Roswell Park Cancer Institute

PROTOCOL TITLE: Does increased mobility assessed with 3D motion tracking technology lead 
to early post-operative recovery among patients undergoing oncologic surgeries
Page 1 of 13
02/28/20
PROTOCOL TITLE:
Does increased mobility assessed with 3D motion tracking technology lead to early post-
operative recovery among patients undergoing oncologic surgeries
PROTOCOL NUMBER:
I 80918      
NCT04000581
PRINCIPAL INVESTIGATOR:
Khurshid Guru, MD
Roswell Park Comprehensive Cancer Center
Elm and Carlton Street
Buffalo, New York 14263
716-845-4155
Khurshid.Guru@roswellpark.org
VERSION NUMBER:
V3
DATE:
02/28/20
Confidentiality Statement
Any and all information presented in this document shall be treated as confidential and shall 
remain the exclusive property of the party (ies) mentioned above (Roswell Park Cancer Institute 
Corporation d/b/a Roswell Park Comprehensive Cancer Center). The use of such confidential 
information must be restricted to the recipient for the agreed purpose and must not be disclosed, 
published, or otherwise communicated to any unauthorized persons, for any reason, in any form 
whatsoever without the prior written consent of the party(ies) above.
APPROVED RPCI IRB
3/10/2020

PROTOCOL TITLE: Does increased mobility assessed with 3D motion tracking technology lead 
to early post-operative recovery among patients undergoing oncologic surgeries
Page 2 of 13
02/28/20
Table of Contents
1
Objectives ................................................................................................................................3
2
Background..............................................................................................................................3
3
Inclusion and Exclusion Criteria .............................................................................................3
4
Local and Study-Wide Number of Subjects ............................................................................4
5
Local and Study-Wide Recruitment Methods .........................................................................4
6
Multi-Site Research .................................................................................................................4
7
Study Timelines.......................................................................................................................4
8
Study Endpoints.......................................................................................................................4
9
Procedures Involved ................................................................................................................5
10
Withdrawal of Subjects............................................................................................................5
11
Risks to Subjects......................................................................................................................6
12
Potential Benefits to Subjects ..................................................................................................6
13
Data and Specimen Banking....................................................................................................6
14
Safety Reporting ......................................................................................................................6
15
Data Management and Confidentiality....................................................................................6
16
Statistical Plan .........................................................................................................................6
17
Vulnerable Populations............................................................................................................7
18
Community-Based Participatory Research..............................................................................7
19
Sharing of Results with Subjects .............................................................................................7
20
Setting......................................................................................................................................7
21
Provisions to Protect the Privacy Interests of Subjects ...........................................................7
22
Resources Available ................................................................................................................7
23
Prior Approvals........................................................................................................................8
24
Economic Burden to Subjects..................................................................................................8
25
Consent Process.......................................................................................................................8
26
Process to Document Consent in Writing................................................................................8
27
Drugs or Devices .....................................................................................................................9
28
References..............................................................................................................................10
29
Appendices/ Supplements......................................................................................................11
APPROVED RPCI IRB
3/10/2020

PROTOCOL TITLE: Does increased mobility assessed with 3D motion tracking technology lead 
to early post-operative recovery among patients undergoing oncologic surgeries
Page 3 of 13
02/28/20
1
OBJECTIVES

To investigate objectively using evidence based randomized controlled trial the impact of 
early mobility (first day after the surgery) after any inpatient oncologic procedures on 
early recovery of postoperative course.

Try to find out the minimum level of postoperative mobility that needed for early 
postoperative course recovery by objective assessment of range of movement for each 
participant using 3D motion tracking system (Xsens)
2
BACKGROUND
Early mobilization is considered an important element of postoperative care, however, it remains 
unclear how to best implement this intervention in clinical practice. One of the first surgeons to 
describe the concept of early mobilization after surgery was Dr. Emil Ries, a gynecologist in 
Chicago, in 1899 (1). Despite the report by Ries, the practice of early postoperative mobilization 
was slow to gain favor in North America and patients were still commonly kept on strict bed rest 
for several weeks after surgery to minimize pain and ensure adequate healing of wounds (2). It 
was not until the 1940s that early mobilization became accepted among surgeons after a number 
of observational studies suggested that this practice was not harmful to patients. Within the last 
20 years, there has been significant progress in perioperative care with the development of 
standardized enhanced recovery pathways (ERPs). ERPs combine many different elements of 
care in the preoperative, intraoperative and postoperative periods, and aim to reduce morbidity, 
decrease hospital duration of stay, and improve patients' recovery after surgery (6). ERPs are 
comprised of up to 25 different interventions in the perioperative period; however, the relative 
contribution of each of these elements to the overall recovery process remains unclear.
Guidelines for perioperative care from the Enhanced Recovery after Surgery Society give early 
mobilization a strong recommendation grade, despite a very low level of evidence supporting its 
use. There is little evidence in the literature regarding strategies to promote compliance to early 
mobilization, and significant differences in mobilization goals exist between programs.
The use of 3D motion tracking technology in clinical practice  started in 2017(10).This 
technology uses wireless inertial measurement units  which could be used in clinical settings to 
objectively measure movement patterns (the joint range of movement and  the distance of 
movement) during functional activities .  These data analyzed by the software and yield further 
calculation representing the bio-kinematics of body movement.
3
INCLUSION AND EXCLUSION CRITERIA
Inclusion Criteria
To be included in this study, participants must meet the following criteria:
1. Age ≥ 18 years of age.
2. Ambulant inpatient with a stay of ≥ 2 days after any oncologic surgery.
3. ECOG scale of performance status of less than 3.
4. American Society of Anesthesiologist score (ASA) 3 or less
APPROVED RPCI IRB
3/10/2020

PROTOCOL TITLE: Does increased mobility assessed with 3D motion tracking technology lead 
to early post-operative recovery among patients undergoing oncologic surgeries
Page 4 of 13
02/28/20
5. Participants who do not engage in regular exercise regimen before the 
surgery (other than regular occupational physical therapy).
6. Participant or legal representative must understand the investigational nature 
of this study and sign an Independent Ethics Committee/Institutional 
Review Board approved written informed consent form prior to receiving 
any study related procedure.
Exclusion Criteria
Patients with altered mental status, psychiatric illness, ECOG scale performance status 3 or 
more, ASA score of 4, participants who engage in regular exercise regimen before surgery (at 
least one session per week), restricted movement due to other diseases or those who require 
continuous monitoring will be excluded from this study.
Inclusion of Women and Minorities
Women and members of all races and ethnic groups are eligible for this study.  Pregnant women 
are eligible for this study.
4
LOCAL AND STUDY-WIDE NUMBER OF SUBJECTS
80 patients will be included in this study. All data will be identified and the duration of the study 
will be 24 months. Participant recruitment will occur through written informed consent prior the 
start of the study after thorough description.
5
LOCAL AND STUDY-WIDE RECRUITMENT METHODS
Subjects will be identified from the Roswell Park Comprehensive Cancer Center Genitourinary 
(GU) clinic and in the inpatient wards when they are scheduled for inpatient oncological surgical 
procedures.  All clinic staff will be informed about the study to help with recognizing patients.  
When a potential patient is identified in clinic, one of the study team members will be notified 
and will discuss the study aims, risks and benefits.  The subject will then be asked to sign an 
informed consent after proper review.
6
MULTI-SITE RESEARCH 
N/A
7
STUDY TIMELINES
The study duration is 24 months or until target accrual is reached. Subjects will be on study until 
they are discharged from the hospital. Subjects will be followed 30 days post discharge to note 
any complications or readmission. A post study questionnaire will be given to participants during 
one of their follow up visits which happen 2 weeks, 6 weeks, 3 months post discharge or over the 
phone if missed. 
8
STUDY ENDPOINTS
The primary study endpoint is measuring early recovery of postoperative course by calculating 
early return of bowel motion (passing flatus and/or stool on which postoperative day), presence 
or absence of nausea and/or vomiting, presence or absence of chest symptoms (cough, sputum 
APPROVED RPCI IRB
3/10/2020

PROTOCOL TITLE: Does increased mobility assessed with 3D motion tracking technology lead 
to early post-operative recovery among patients undergoing oncologic surgeries
Page 5 of 13
02/28/20
and ability of using incentive spirometry), early discharge from the hospital and 30 days surgical 
related complications and readmissions. 
The secondary study endpoint is measuring the range of joint movement in upper and lower 
joints of body, using the 3D motion tracking system (Xsens), to identify the minimum required 
level of mobility for better early postoperative course recovery. 
A few other secondary endpoints concluded from the post experiment questionnaire include: 
assessing encouraged walking in the hospital setting subjectively improves their exercise habit 
outside of the hospital, how was the application of the sensors in a hospital setting as this is the 
first study to do so, and to assess the subjective impact of complications on quality of life.
9
PROCEDURES INVOLVED
This is a prospective randomized controlled trial comparing the early postoperative course of 
patients who undergo inpatient oncological procedures after assessment of their baseline physical 
activity before the surgery, using validated questionnaires in the clinic, to have a homogenized 
sample for the study. Participants will be randomized to the control arm (40 participants) and 
intervention group (40 participants).  Control group participants will be asked to walk one to two 
laps around the ward twice per day, on the first day after the surgery following the usual clinical 
practice at Roswell Park Comprehensive Cancer Center-urology department (RPCCC). Their 
movement will be tracked with 3D motion tracking system (Xsens). The intervention arm 
participants will be asked to walk for minimum 30 minutes per day and their movement also will 
be tracked with Xsens. In both arms the patients will be asked to mobilize (walk out of the bed) 
on first day post-surgery under supervision and assistant of attending nurse in the floor if their 
clinical situation allowed. If patient cannot complete the walking tasks, they will be excluded 
from the study and they will be replaced by recruiting other patients.
 Xsens is a wireless technology that makes use of sensors. The sensors are applied in a non-
invasive manner and do not require the suit to be applied. There are various configurations of the 
sensors that can be utilized. The minimum number of sensors needed is 7. They are applied by 
using Velcro bands. The entire set-up takes about 5-10 minutes.
The study duration is 24 months or until target accrual is reached. In both arms their mobility 
will be tracked till they discharged from the hospital. In both arms we will assess the symptoms 
and signs of gastro-intestinal complications (nausea, vomiting, abdominal pain, passing flatus or 
stool) and chest symptoms (coughing, sputum, utilizing incentive spirometry) until they are 
discharged from the hospital. We will continue to follow them for 30 days post discharge to note 
any complications or readmission.
Patients at standard follow ups, 2 weeks, 6 weeks, 3 months or over the phone will complete a 
short post study questionnaire (Appendix B). The last three questions are taken from Woodfield 
et al., who assessed postoperative problems from the perspective of the patient on the 
identification of complications after surgery (11).
10 WITHDRAWAL OF SUBJECTS
N/A
APPROVED RPCI IRB
3/10/2020

PROTOCOL TITLE: Does increased mobility assessed with 3D motion tracking technology lead 
to early post-operative recovery among patients undergoing oncologic surgeries
Page 6 of 13
02/28/20
11 RISKS TO SUBJECTS
Risk of fall is associated with mobility.  This will be minimalized with standard procedures 
including; patient risk of fall stratification, supervised patient mobility and using balance 
assessment programs.
12 POTENTIAL BENEFITS TO SUBJECTS
There is no direct benefit to subjects.
13 DATA AND SPECIMEN BANKING
N/A
14 SAFETY REPORTING
N/A
15 DATA MANAGEMENT AND CONFIDENTIALITY
Data will be collected through computer logging, note taking, paper/pencil or computer forms. 
Demographic information (position title, years of experience, area of expertise) will be collected 
but names will not be associated with the data. Individual privacy will be maintained in all 
published and written data resulting from the study. Participants will be given a unique code/ID 
number. This number will be used instead of names to identify information collected during the 
study. De-identified data will be kept indefinitely, in paper and electronic form and on computers 
accessible to the investigators and their research assistants.
16 STATISTICAL PLAN
Demographics: Subject demographic and clinical characteristics will be reported by group using 
the appropriate descriptive statistics and graphical summaries. Comparisons will be made 
between groups using the Mann-Whitney U or Chi-square tests, as appropriate.
Randomization: Subjects will be randomized to the control and intervention groups in a 1:1 
fashion using a permutation block design (block sizes = 4). The randomization list will be 
developed by the study statistician.
Primary Analysis: The primary objective is to evaluate changes in mobility between the control 
(standard of care) and intervention (additional activity) groups. The primary outcomes are 
measures of mobility (i.e. range of movement), which are treated as continuous measures and 
will be summarized by group and time-point using the mean, median, and standard deviation. 
The measures of mobility will each be modeled as a function of treatment group, time post-
surgery, their two-way interaction, and random subject effects using a linear mixed model. 
Within each group, the effect of time on the mean will be evaluated using tests about the 
appropriate contrasts of model estimates. The effect of the two groups on the time-mobility 
relationship will be evaluated using an F-test about the interaction term. All model assumptions 
will be evaluated graphically and transformations will be applied as necessary.
Secondary Analyses: The secondary objective is to evaluate the impact on post-surgical 
complications. The complication status (present/absent) and grades will be summarized by group 
and compared using Fisher’s exact test or the chi-square test, as appropriate.
APPROVED RPCI IRB
3/10/2020

PROTOCOL TITLE: Does increased mobility assessed with 3D motion tracking technology lead 
to early post-operative recovery among patients undergoing oncologic surgeries
Page 7 of 13
02/28/20
The association between complication status and changes in measures of mobility may be 
evaluated using logistic regression models.
Sample Size Determination: The power calculations are based on the primary analysis, which 
compares the changes in measures of mobility between the two groups. Since the form of the 
models is unknown beforehand, a simplified and conservative power calculation is based on 
comparing the mean change (baseline to discharge) in a given mobility measure between groups 
using a two-sided, two-sample t-test. With a sample size of n=40 per group, we have 80% power 
(at α = 0.05) to detect a difference of at least 0.63 standard deviations. Such a moderate effect 
size would be considered clinically relevant.
17 VULNERABLE POPULATIONS
N/A
18 COMMUNITY-BASED PARTICIPATORY RESEARCH
N/A
19 SHARING OF RESULTS WITH SUBJECTS
N/A
20 SETTING
The potential subjects will be identified in the genitourinary clinic at Roswell Park 
Comprehensive Cancer Center where they will meet with one of the research team members and 
in the inpatient wards.  
The research procedure will be performed at Roswell Park 
Comprehensive Cancer Center inpatient wards.  
21 PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF SUBJECTS
Participants will be free to determine whether to respond to requests for participation. All 
participants, even after providing consent, are free not to answer any questions, or choose to end 
their participation and thus can privately maintain control over the level of information provided 
to us. No PHI will be recorded.
Data will be stored on a secured, password protected RPCI server in the Urology department that 
is maintained by the information technology department. Access will be limited to the PI and 
Coinvestigator’s.
22 RESOURCES AVAILABLE
Our research team comprises of surgeons, clinical and research fellows, research assistants and 
coordinators. Our diverse team has worked on similar projects and has extensive experience in 
undergoing clinical trials. Dr. Khurshid Guru’s laboratory, the Advanced Technologies 
Laboratory for Advanced Surgery (ATLAS) is located at Grace Cancer Drug Center is 
approximately 1400 sq. feet. A major portion of the lab is dedicated for industrial and human 
factor engineering researches and sciences. The laboratory is fully equipped to safely carry out 
and develop the proposed work. The laboratory personnel comprised of surgeons, clinical and 
research fellows, medical illustrators and engineers are highly experienced in conducting clinical 
research. The innovative multidisciplinary team utilizes the lab space for equipment storage and 
APPROVED RPCI IRB
3/10/2020

PROTOCOL TITLE: Does increased mobility assessed with 3D motion tracking technology lead 
to early post-operative recovery among patients undergoing oncologic surgeries
Page 8 of 13
02/28/20
data analysis. Space and network access are readily available throughout the study period. The 
PI, Dr. Khurshid Guru, and the research team members have their dedicated equipped work 
space with secretarial support. All participating research members will receive an in-service that 
adequately explains the research protocol, procedures and individual duties.
23 PRIOR APPROVALS
N/A
24 ECONOMIC BURDEN TO SUBJECTS
There are no costs to the subjects.
25 CONSENT PROCESS
This study will not be initiated until the protocol and informed consent document(s) have been 
reviewed and approved by a properly constituted Institutional Review Board (IRB) or 
Independent Ethics Committee (IEC). Each participant (or legal guardian) shall read, understand, 
APPROVED RPCI IRB Protocol and sign an instrument of informed consent prior to 
performance of any study-specific procedure. It is the responsibility of the investigator to ensure 
that the participant is made aware of the investigational nature of the treatment and that informed 
consent is given. The Investigator is responsible for the retention of the participant log and 
participant records; although personal information may be reviewed by authorized persons, that 
information will be treated as strictly confidential and will not be made publicly available. The 
investigator is also responsible for obtaining participant authorization to access medical records 
and other applicable study specific information according to Health Insurance Portability and 
Accountability Act regulations (where applicable). This study will be conducted in compliance 
with all applicable laws and regulations of the state and/or country and institution where the 
participant is treated. The clinical trial should be conducted in accordance with the ethical 
principles embodied in the Belmont Report: Ethical Principles and Guidelines for the Protection 
of Human Subjects of Research, consistent with good clinical practice and the applicable 
regulatory requirements and according to the guidelines in this protocol, including attached 
appendices. The RPCI SOP: Informed Consent Process for Research (HRP-090) will be 
followed.
This study will be conducted in compliance with all applicable laws and regulations of the state 
and/or country and institution where the participant is treated. The clinical trial should be 
conducted in accordance with the ethical principles embodied in the Belmont Report: Ethical 
Principles and Guidelines for the Protection of Human Subjects of Research, consistent with 
good clinical practice and the applicable regulatory requirements and according to the guidelines 
in this protocol, including attached appendices.
26 PROCESS TO DOCUMENT CONSENT IN WRITING
The Investigator (or IRB specified designee) is responsible for obtaining written consent from 
each participant or the participant's legally authorized representative in accordance with GCP 
guidelines using the approved informed consent form, before any study specific procedures 
(including screening procedures) are performed. The informed consent form acknowledges all 
information that must be given to the participant according to applicable GCP guidelines, 
including the purpose and nature of the study, the expected efficacy and possible side effects of 
APPROVED RPCI IRB
3/10/2020

PROTOCOL TITLE: Does increased mobility assessed with 3D motion tracking technology lead 
to early post-operative recovery among patients undergoing oncologic surgeries
Page 9 of 13
02/28/20
the treatment(s), and specifying that refusal to participate will not influence further options for 
therapy. Any additional information that is applicable to the study must also be included. 
Additional national or institutionally mandated requirements for informed consent must also be 
adhered to. The participant should also be made aware that by signing the consent form, 
processing of sensitive clinical trial data and transfer to other countries for further processing is 
allowed. The Investigator shall provide a copy of the signed consent form to the participant and 
the signed original shall be maintained in the Investigator File. A copy of the signed consent 
form must be filed in the participant file. At any stage, the participant may withdraw from the 
study and such a decision will not affect any further treatment options. The RPCC “SOP: Written 
Documentation of Consent (HRP-091)” will be followed. 
27 DRUGS OR DEVICES
3D motion tracking system (Xsens) is commercially available device used in research, especially 
sport medicine.  These devices will not be used for any off label purposes.  They will be stored in 
the ATLAS lab (G-401).
APPROVED RPCI IRB
3/10/2020

PROTOCOL TITLE: Does increased mobility assessed with 3D motion tracking technology lead 
to early post-operative recovery among patients undergoing oncologic surgeries
Page 10 of 13
02/28/20
28 REFERENCES
1.
G.H. Brieger; Early ambulation. A study in the history of surgery
2.
D.J. Leithauser, H.L. Bergo; Early rising and ambulatory activity after operation: a means of 
preventing complications
3.
V. D'Ingianni; Early and late postoperative ambulation: a comparative study of three hundred and 
three cases
4.
Bed rest, thrombosis, and embolism Lancet, 1 (1958), pp. 465-466
5.
H.M.D.P. Kehlet, D.W.M.D. Wilmore; Evidence-based surgical care and the evolution of fast-track 
surgery Ann Surg, 248 (2008), pp. 189-198
6.
K.K. Varadhan, D.N. Lobo, O. Ljungqvist; Enhanced Recovery after surgery: the future of improving 
surgical care Crit Care Clin, 26 (2010), pp. 527-547
7.
U.O. Gustafsson, M.J. Scott, W. Schwenk, N. Demartines, D. Roulin, N. Francis, et al.; Guidelines for 
perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS®) Society 
recommendations World J Surg, 37 (2013), pp. 259-284
8.
M.S. Vlug, S.A.L. Bartels, J. Wind, D.T. Ubbink, M.W. Hollmann, W.A. Bemelman, et al.; Which fast 
track elements predict early recovery after colon cancer surgery? Colorectal Dis, 14 (2012), pp. 
1001-1008
9.
N.J. Smart, P. White, A.S. Allison, J.B. Ockrim, R.H. Kennedy, N.K. Francis; Deviation and failure of 
enhanced recovery after surgery following laparoscopic colorectal surgery: early prediction model 
Colorectal Dis, 14 (2012), pp. e727-e734
10. Mohammad Al-Amri  , Kevin Nicholas , Kate Button , Valerie Sparkes , Liba Sheeran  and Jennifer L 
Davies . Inertial Measurement Units for Clinical Movement Analysis: Reliability and Concurrent 
Validity. Sensors 2018, 18(3), 719; doi:10.3390/s18030719
11. Woodfield J, Deo P, Davidson A, Chen TY, van Rij A. Patient reporting of complications after surgery: 
what impact does documenting postoperative problems from the perspective of the patient using 
telephone interview and postal questionnaires have on the identification of complications after 
surgery? BMJ Open. 2019;9:e028561.
APPROVED RPCI IRB
3/10/2020

PROTOCOL TITLE: Does increased mobility assessed with 3D motion tracking technology lead 
to early post-operative recovery among patients undergoing oncologic surgeries
Page 11 of 13
02/28/20
29 APPENDICES/ SUPPLEMENTS
APPROVED RPCI IRB
3/10/2020

PROTOCOL TITLE: Does increased mobility assessed with 3D motion tracking technology lead 
to early post-operative recovery among patients undergoing oncologic surgeries
Page 12 of 13
02/28/20
Appendix A:
Xsens Motion Tracking Technology
APPROVED RPCI IRB
3/10/2020

PROTOCOL TITLE: Does increased mobility assessed with 3D motion tracking technology lead 
to early post-operative recovery among patients undergoing oncologic surgeries
Page 13 of 13
02/28/20
Appendix B. 
Post study questionnaire documenting postoperative problems from the perspective of the patient 
and study feedback
Post Experiment Questionnaire
Participant ID: 
Date of Surgery: 
Date of Questionnaire Completion: 
How satisfied were you with the process of applying of sensors?
Very Unsatisfied
Unsatisfied
Neutral
Satisfied
Very Satisfied
Were the sensors comfortable throughout your wear?
Very 
Uncomfortable
Uncomfortable
Neutral
Comfortable
Very 
Comfortable
Did having the sensors on push you to walk more?
Very Unlikely
Unlikely
Neutral
Likely
Very Likely
How much of your previous mobility have you regained since the operation?
0%
25%
50%
75%
100%
Have you been pushing yourself to exercise since the operation?
Never
Rarely
Sometimes
Often
Always
How Much Pain Do You Feel Day to Day?
Not At All
A Little Bit
Moderately
Quite A Bit
Extremely
Your quality of life now compared to the month before the surgery?
A lot worse
Somewhat 
Worse
About the Same
Somewhat 
Better
A Lot Better
How Do You Feel About Yourself as A Result Of Your Surgery? 
A lot worse
Somewhat 
Worse
About the Same
Somewhat 
Better
A Lot Better
APPROVED RPCI IRB
3/10/2020