Virtual Prehabilitation of Surgical Cancer Patients in Times of the Covid-19 Pandemic
Phase: NA
Conditions: Abdominal Cancer, Thoracic Cancer
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

 
 
i 
Virtual Prehabilitation of Surgical Cancer Patients in Times of the 
Covid-19 Pandemic  
 
Approved by MUHC-IR REB on January 5th, 2021 (#2021-6730) 
 
Co-Principal Investigator  
Franco Carli, MD. MPhil 
Department of Anesthesia, McGill University Health Center  
 
Sender Liberman, MD. 
Department of Surgery, Division of General Surgery, McGill University Health Center.  
Amal Bessisow, MD.  
Department of Internal Medicine, McGill University Health Center.  
Collaborators  
Anesthesiologists  
Department of Anesthesia, McGill University Health Center. (Dr. Enrico M. Minnella MD., Dr. 
Gabriele Baldini, MD.) 
Surgeons 
Division of Thoracic Surgery, McGill University Health Center. (Dr. Jonathan Spicer, MD., Dr. 
Lorenzo Ferri, MD., Dr. Jonathan Cools, MD.) 
Division of General Surgery, McGill University Health Center. (Dr. Patrick Charlebois, MD., Dr. 
Barry Stein, MD., Dr. Larry Lee, MD.) 
Nutritionist 
Chelsia Gillis, RD. & Teodora Cioteanu, RD. 
Kinesiologist  
Department of Experimental Surgery, McGill University Health Center. (Dr. Louis-Nicolas 
Veilleux, PhD.) 
Department of Kinesiology, McGill University. (Celena Scheede-Bergdahl, PhD.) 
Nursing 
Linda Jean Edgar &  Ibby Shulter  
Project Coordinator   
Bhagya Tahasildar, MD.  
 
Graduate Student 
Genevieve Lambert, B.Sc. 
Department of Experimental Surgery, McGill University. 
 
Research Assistant  
Kenny Drummond, B.Sc. 
Department of Experimental Surgery, McGill University. 
 
 
 

 
 
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Table of Content 
Virtual Prehabilitation of Surgical Cancer Patients in Times of the Covid-19 Pandemic
 ..................................................................................................................................... i 
Study purpose and rationale ........................................................................................ 1 
Aims & Hypothesis ............................................................................................................................... 2 
Description of study population ................................................................................... 2 
Patients .................................................................................................................................................. 2 
Sample Size ........................................................................................................................................... 3 
Standards of Care & Hospital Procedures ................................................................... 3 
MUHC Standard of Care During Pandemic .......................................................................................... 3 
Design and description of methodology ....................................................................... 3 
Quality Improvement (QI) study ........................................................................................................... 3 
Recruitment ........................................................................................................................................... 3 
Evaluation process ................................................................................................................................. 4 
Program Administered ........................................................................................................................... 4 
Material for participants ........................................................................................................................ 6 
Definition of endpoints ................................................................................................ 6 
Feasibility and timeline ......................................................................................................................... 6 
Facilities available ................................................................................................................................. 6 
Measurements and study instruments .......................................................................... 6 
Outcome measures ................................................................................................................................. 6 
Primary outcome ................................................................................................................................... 6 
Secondary outcomes .............................................................................................................................. 7 
Data analysis plan ....................................................................................................... 7 
Details on confidentiality ............................................................................................. 8 
Confidentiality ....................................................................................................................................... 8 
Data Collection, Storage & Security, Handling and Record Keeping ................................................... 8 
Statement on ethical considerations ............................................................................. 9 
References: ............................................................................................................... 10 
 

 
 
1 
 
Study purpose and rationale  
In light of the coronavirus (COVID -19) pandemic, the World Health Organization has warned of 
the possible loss of cancer surgery over the next 8 months and risk of death of many of these patients 
awaiting surgery dates. The pandemic has a major impact on everyday life of these patients, such 
as social distancing and physical isolation resulting in decline of physiological and psychological 
reserves. Lack of physical activity can lead to autonomic impairment and rapid loss of lean body 
mass and muscle strength (1). The psychological impact includes anxiety and depression, which in 
older people may contribute to cognitive decline or dementia. In addition, patients presenting for 
cancer surgery tend to have more comorbidities associated with reduced physical fitness and 
moderate-to-high levels of malnutrition. Such deterioration in health can progress even further, 
leading to cancer treatment-related complications and delayed surgical recovery (2). Interventions 
aimed to mitigate these side effects and engage patients to be resilient, while increasing their 
physiological fitness are crucial to improving clinical trajectories and are particularly relevant at 
this time given the current global pandemic (3).  
 
Prehabilitation, a process of engaging patients to enhance their functional capacity before surgery 
with the aim to enhance tolerance to the physiological stress of surgery and recovery, has been 
shown to improve physical fitness, reduce length of hospital stay, improve health-related quality of 
life and reduce postoperative complications, with evidence of reducing healthcare costs. 
Prehabilitation has been shown to be more effective at improving exercise capacity than 
rehabilitation, moreover the benefits of prehabilitation are sustained postoperatively. Several 
studies from the Peri-Operative Program (POP) of the McGill University Health Centre (MUHC) 
on prehabilitation for cancer patients have shown improved recovery, earlier return to baseline 
functional capacity, reduced severity of complications, prolonged 5-year disease-free survival. This 
is a salient time to empower our participants in taking care of their health before and after surgery 
(4). 
 
The Prehabilitation POP program of the MUHC includes personalized exercise training (aerobic, 
resistance, flexibility and balance), nutritional optimization and supplementation, emotional and 
psychological support, and behavioural changes (alcohol and smoking cessation) (5). The 
multidisciplinary POP team includes anesthesiologists, surgeons, internists, geriatricians, 
nutritionists, exercise physiologists, psychology-trained personnel, volunteers, graduate students. 
Over the last 10 years over 500 cancer patients have been included in several POP randomized 
controlled trials on the effect of home-based and supervised prehabilitation.  
 
The present QI proposal has been set up in response to the reaction from our cancer patients enrolled 
in RCTs when we had made the decision on March 13th to close the Prehabilitation Clinic. Our 
participants were devastated when we informed them that the trials and the referrals from surgeons 
to the prehabilitation clinic were being paused. We continued to call them at home on a weekly 
basis and a majority of them continue to exercise, eat well and relax. A telephone line was opened 
to them in case they needed additional support. Our kinesiologists, nutritionists and psychosocial 
personnel have been able to provide support remotely. Support provided via telephone, however, 
has limitations: firstly, it limits the social component of seeing someone, as patients don’t see the 
healthcare providers, and secondly, it is not feasible to recruit or to administer a prehabilitation 
through telephone-delivery, without seeing patients beforehand. 
 
A recent study by Cherid et al.(2020 (6)), reported that elderly populations were increasingly 
knowledgeable in the use of technologies, with significant satisfaction from both patients and 
clinicians (7). Therefore, distanced delivery of health interventions with proper technological 
support to patients could enable prehabilitation staff to address the limitations previously 

 
 
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mentioned. The current study proposes the use of two technologies that have been discussed in the 
literature: a videoconferencing application and a training watch. Videoconferencing has proven to 
be effective in the delivery of rehabilitation after surgery (8) and have positive effects on patients’ 
recovery. Videoconferencing has further proven to be feasible to deliver nutritional and 
psychological counseling (9,10). Additionally, with the technological advancements, trainings 
watch can now provide many tools to helps users be more aware of their daily habits in order to 
improve their lifestyle. Quantifying their sleep (11), relaxation time, physical activity (12) or 
inactivity (13) can help patients to obtain objectives. 
 
There is a general concern that the backlog of cancer patients waiting for surgery during this 
period is going to increase and the general impact on patients isolated in their homes is going 
to cause potential physiological and psychological impairments. Therefore, we propose a 
distanced-delivered personalized home-based prehabilitation program to all cancer patients 
scheduled for surgery at the MUHC. The program will be delivered by qualified 
professionals, supported by technology provided by POP, to all cancer patients waiting for 
surgery, addressing the patients’ risk factors in patients’ pandemic reality perspective. 
Participant contacts will primarily occur virtually using technologies such as video 
conferencing and digital applications. This will enable us to continue to support people with 
cancer and deliver safe remote counseling by specialist healthcare providers in their own 
homes, whilst adhering to the Governmental guidelines on social distancing, self-isolation and 
shielding.  
 
 
Aims & Hypothesis  
 
1. To assess the feasibility of a distance-delivered prehabilitation program to oncologic 
surgical candidates in light of the current global pandemic. 
 
2. To measure the effect of technology-supported prehabilitation on preoperative and 
postoperative functional capacity and clinical outcomes 
 
3. To qualitatively investigate the impact of distance-delivery of prehabilitation on health-
related quality of life, anxiety and depression, which may be exacerbated by the current 
global phenomenon. 
 
It is hypothesized that distance-delivery of prehabilitation will be feasible if it provides comparative 
adherence and completion rates to internal data from pre-pandemic home-based programs of 71% 
(5)and 66% (ClinicalTrials.gov Identifier: NCT03361150), respectively. 
Description of study population 
Patients 
Study Group: 100 patients on the waiting lists to undergo elective thoracic and abdominal surgery, 
initially at the Montreal General Hospital (MGH). Approximately 500 patients are operated at the 
MGH for lung, esophageal, stomach and colorectal cancer surgery per year.  
 
Patients will be screened by the medical research team for health conditions that would prohibit 
participation in the program, at any moment prior to their surgery.  
 
Inclusion criteria: 
● Adults scheduled for elective cancer surgery that is delayed due to COVID-19 
referred by a surgeon;  
● Covered by the RAMQ 

 
 
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● Have medical clearance to exercise (as provided on the physician referral);  
● Are able to understand English or French. 
 
 
Sample Size  
A convenient sample size of 100 cancer patients is based on the evaluation of adherence to the 
home-based virtual prehabilitation program. In a previous home-based study, we reported an 
adherence rate to prehabilitation of 78%; n = 38 (14) prior to surgery. We assume that the adherence 
rate in the present study will not be inferior because, despite being isolated at home, patients will 
have access to a video and a watch to encourage them to be active and engaged in the program. In 
consideration of Covid-19, we will start by enrolling 10-15 patients to determine which issues 
might be generated (problems with the internet, change in surgical wait list, drop out). As per our 
experience we expect 20% refusal to participate and 20% loss to follow-up. 
Standards of Care & Hospital Procedures  
MUHC Standard of Care During Pandemic 
The standard of care is currently compromised given the global COVID-19 circumstances. As a 
result, the quality of care provided to surgical candidates is restricted.  
Many surgeries have been postponed indefinitely, largely due to the restrictions imposed on 
allowed volume of surgeries performed per day. Currently, more than 100, 000 patients have been 
placed on surgical waitlists across the country(15). This number is expected to continue to rise with 
new patients diagnosed each day. As a result, many patients have been provided with an alternative 
neoadjuvant therapy, however, remain uncertain of when they will receive the curative surgery that 
they require. 
 
Between diagnosis and surgery patients are encouraged not to visit the hospitals due to their 
compromised health status and the increased risk it might impose of potential exposures. Patients 
therefore have limited access to perioperative supportive care between diagnosis and surgical 
recovery.  
 
Contrary to the pre-pandemic period, patients are not being seen by nurses and anesthetists in the 
pre-operative assessment clinic, and therefore do not receive the same quality of care 
preoperatively. Further, postoperatively, patients are confined to their rooms and not permitted to 
ambulate the corridors and visits by healthcare professionals are restricted.  
 
In order to promote a safe hospital environment, patients are asked to come in the day before 
surgery to perform a precautionary test to identify if they are positive carriers of the COVID-19 
virus. This beside the visit at the clinic when the surgeon will finalize the suitability for surgery. 
Design and description of methodology  
Quality Improvement (QI) study 
This QI study will include one group of 100 patients who will receive distance-delivered support 
for all components of the home-based prehabilitation regimen in addition to 2 months of follow-up 
post-surgery. The program will include: exercise, nutrition, mental well-being and, if needed, 
smoking cessation. The technologies (a tablet and an active lifestyle watch) will be used to provide 
counselling, educate patients on lifestyle modifications and assess adherence remotely. Telephone 
calls will also be made on a weekly basis, if participants were unable to attend their video-
conferencing counselling sessions.  
 
Recruitment 
Surgeons will mention that the study coordinator and the prehab team will contact and explain the 
nature of the study. If the patient is in agreement, he or she will then receive a phone call from a 

 
 
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prehabilitation team member to inquire about their interest in the project (discussion during which 
the project will be explained) and the available technologies (internet & technologies accessibility). 
Additionally, an appointment will be made for the drop-off of the required material and initial 
assessment (via videoconferencing). Baseline will be done within the following week. Two copies 
of the consent form will be signed during the initial assessment (if at the hospital) or during the the 
drop-off (if assessment done via videoconferencing), in a way that respects social distancing and 
other measures recommended by public health agencies and Centre de coordination des mesures 
d'urgence (CCMU) of the MUHC. The baseline evaluation is conducted by the physician, the 
kinesiologist & the nutritionist. 
 
Evaluation process 
Once the program has been explained to the patient and consent has been obtained by the 
prehabilitation team, together they will agree on a day in the following week for baseline 
evaluation. Baseline and subsequent evaluations will be conducted either in clinic, or over 
videoconference, depending on the evolving recommendations from the Public Health Authorities 
and CCMU of the MUHC. The duration of the evaluation will take approximately half an hour 
and will assess functional tasks such as, if possible, a patients’ abilities to walk, stand up from a 
chair, in addition to answering several questionnaires. All components of the evaluation will be 
explained in advance to the patient, in order to assess level of comfort towards the tasks. If a patient 
does not feel comfortable executing any of the tasks, the latter task will not be done. The baseline 
evaluation will be followed by a 45 minutes technical workshop on the different pre-set applications 
and educational video content available on the tablet and the training watch, Polar watch (16). The 
patient will receive the multidisciplinary program following the initial evaluation up until surgery: 
the counseling with the healthcare providers will be done at home through the use of the tablet, and 
adherence to the different parts will be assessed with both survey and data from the Polar watch. 
Therefore, the patients will only have to come to the hospital for essential medical appointments. 
Patients will perform assessments at four time points, at baseline, 24 hours prior to surgery, in 
addition to 4- and 8-weeks after surgery. 
 
Program Administered  
The current project aims to improve the quality of care delivered to oncologic surgical candidates 
during the COVID-19 pandemic. The program for the current study will consist of two parts, the 
first being individual counselling with different healthcare professionals, the second component 
would be a home-based prehabilitation program.  
 
The healthcare providers available for participants' respective needs include exercise physiologist, 
nutritionists and psychosocial personnel who would contact patients via phone, and a 
videoconferencing platform (Zoom(17)) if possible, facilitated by the use of the tablet.  
Exercise physiologists will follow-up with patients regularly throughout the continuum of care 
(before and after their surgery(14)) and refer them to the relevant specialists as needed.  
The patients will also have access to premade videos prepared by POP to provide additional support 
in their application of the preoperative recommendations: physical activity (aerobic, resistance, and 
flexibility), nutrition optimization (healthy eating, improving protein and energy intake, portion 
size, glycemic control), psychological exercises (breathing exercise, relaxation, imaging, 
visualization) and smoking cessations. These videos will be available to the patients on their tablet, 
in addition the exercises will be demonstrated in the booklets.  
 
Exercise Recommended Program 
As previously discussed, patients’ mobility and capacity to undertake exercise will be evaluated 
before establishing the personalized exercise program. They will receive explanations of the 
program and their adherence to the latter will be monitored using a Polar watch. Patients will be 
instructed on how to perform aerobic exercise at home, by either walking or cycling initially at 
50% of the calculated heart rate reserve for a cumulative minimum target of 30 minutes per day 

 
 
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(minimum bouts of 10 minutes), five times per week. Exercise volume or intensity will be increased 
in stepwise increments by 10% each week, if tolerable. Resistance training will also be encouraged, 
and patients will be asked to complete a series of 8 exercises targeting the major muscle groups 
three times per week. The exercises will be performed using bodyweight and/or elastic band until 
volitional fatigue. Patients will be asked to perform 8-12 repetitions of each exercise for a total of 
2-3 sets.  
Physical safety will be addressed by, firstly, before establishing recommendations exercises, 
evaluating the patient's functional capacities. This ensures the safety of every participant in their 
physical activity program done at home.  
 
Nutritional Component: Supplementation and Follow-ups  
The patients’ nutritional status and dietary intake will be assessed by the nutritionist. The dietician 
will use basic anthropometrics and laboratories, in addition to a nutritional screening tool (PGS-
GA) to help them assess a patient’s dietary needs and extent of nutritional disparity. All patients 
will receive daily dietary supplements of whey protein. Special precautions will be considered if 
patients have specific medical conditions (e.g. diabetes). The supplementations will be given at the 
initial drop-off.  
Nutritionist assessment and recommendation will be made through video-conferencing application 
within the first week of enrolment. Additional counselling sessions will be possible through 
videoconferencing, depending on patients’ needs. Furthermore, to assess adherence to the 
nutritional recommendations, the patient will be instructed to take pictures of their food at once per 
week. These pictures will be sent to the dietician.  
 
Psychological Component  
Not surprisingly, patients recently diagnosed for cancer and awaiting major surgical resections 
often experience high levels of anxiety, depression and emotional distress. This can be further 
exacerbated when surgeries are delayed for reasons outside of their control. Since both anxiety and 
depression can influence patient motivation and willingness to adhere to clinical interventions, 
psychological strategies can be an important element in the cancer care continuum and help patients 
to cope with the stress of the disease and surgery. For this reason, patients will have access to a 
total of 1.5 hours of mental relaxation and coping mechanisms program within the first week of 
enrolment, using videoconferencing. However, given that patients experience varying degrees of 
emotional distress, more sessions will be provided as needed. In the first session with the 
psychologist trained personnel, the first hour will address the patient’s anxieties, coping strategies, 
and post-operative expectations, with the goal of optimizing psychological well-being & ways of 
coping with surgery. The importance of the patient’s active participation in the healing process will 
also be discussed. The last thirty minutes will be devoted to teaching relaxation techniques and 
breathing exercises. Patients will be given relaxation exercise recordings on the tablet to practice 
at home. Further, the adherence to the psychological well-being recommendations will be assessed 
through the Polar watch which will provide the information about frequency and duration of the 
home relaxation, deep breathing and positive thinking self-administered exercises, goal-based on 
discussion at the first counseling. 
 
Lifestyle modification Component 
Patients with smoking habits will be able to meet with a respiratory specialist through 
videoconferencing. The respiratory specialist establishes recommendations and will contact the 
physician for the recommended smoking cessation protocol. Moreover, the respiratory specialist 
will explain the use of the Inspiratory Muscles Trainer (IMT) to be done at home. The patient will 
be instructed to use the IMT every day, for a minimum of 2 series, each consisting of 30 breaths 
each. Weekly improvement will be assessed through the home-based videoconferencing.  
 

 
 
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Material for participants 
In addition to the standard material provided in previous prehabilitation studies (booklet, nutritional 
supplement, relaxation recording, elastic band & IMT device), patients in this cohort will have 
access to two technological tools.   
The two tools are used to assess adherence to the different parts of the program: 1. a Polar watch 
and 2. a tablet which will be loaned to them for the duration of the study with their respective 
chargers.  
1. The Polar watch will allow them to monitor their heart rate, and physical activity volume 
and intensity during the aerobic and resistance training, in addition to daily activities. Then 
this information will be sent to the exercise physiologist. In addition, it provides a step 
counter which will help set goals for the patients and monitor the progress by the 
prehabilitation team. 
2. The tablet will create a platform of communication between the patient and the 
multidisciplinary prehabilitation team. On the tablet provided with data (internet access), 
patient will have access to: a) reference videos about the different aspects of their 
prehabilitation program, b) videoconferencing and chat application to communicate with 
the family and healthcare professionals (zoom), c) a calendar to remind them of counseling 
appointments, d)a daily 3-questions survey concerning adherence, e) an application to track 
their physical activity progress, f) audio recordings for the relaxations and coping 
exercises, g) questionnaires and tools for baseline, preoperative assessment and post-
operative follow-ups. We will contact the MUHC IT department to format the tablets (with 
their content and applications) in order to ensure that all material has the same settings with 
the right security settings applied. 
Definition of endpoints 
Feasibility and timeline 
Approximately 500 thoracic and abdominal resections are performed annually at the Montreal 
General Hospital. If 75% of patients are eligible, and 75% of them agree to participate, we would 
enrol, approximately, 3 patients each week (30-45 weeks for enrolment). Thus, one year and half 
period is feasible for completion of this project. 
 
Facilities available 
The investigator is located at the Montreal General Hospital. The project will be run at the human 
performance laboratory in the Department of Anesthesia at the Montreal General Hospital. This lab 
is staffed by exercise physiologists, a nutritionist, research assistants and anesthesia fellows. 
 
Measurements and study instruments   
Outcome measures  
All outcomes will be captured via patient chart review, self-report questionnaires, data collected 
from the Polar watch and digital surveys. Chart review outcomes include length of hospital stay, 
surgical and postoperative complications. 
 
Primary outcome 
The primary outcome of the current study is to assess the feasibility of distance-delivery of 
Prehabilitation to these high priority cancer patients using a digital platform. In order to ascertain 
if the program was feasible, the evaluation criteria included quantitative measures such as 
recruitment rate, adherence to program (self-reported measures and crude data from the polar), 
program completion rate, frequency of technological failures, adverse events, in addition to 
qualitative measures such as rational for refusal to participate, low compliance and drop-outs. 
 

 
 
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Secondary outcomes 
Functional outcomes 
A part of the secondary outcomes of the study include evaluating the impact of the program on 
patient functional capacity, assessed by a 30 second sit-to-stand, time-up and go (TUG), in addition 
to a 2- or 6-minute walk (18,19) test when possible. The above-mentioned assessments are used in 
a variety of clinical settings to quantify patient functional capacity and facilitates the identification 
of higher risk surgical candidates. 
 
Nutritional and Metabolic Status 
Nutritional status will be assessed at baseline, preoperatively and postoperatively. Several measures 
including body mass index (BMI), recent unintended weight loss over the preceding three months 
(> 10%), CRP, and serum albumin < 35 g -1 will be used to define poor nutritional status. The 
MUHC Abridged-Scored patient-generated subjective global assessment (PG-SGA) will also be 
used as a complementary nutritional assessment tool to identify patients at a high risk of 
malnutrition and monitor changes throughout the course of the perioperative period.  
 
Sleep Quality 
The current study will also investigate the impact of a multidisciplinary prehabilitation program on 
sleep duration and quality. The Polar watch will provide the research team with the approximate 
duration of sleep and patient’s satisfaction of their sleep on a nightly basis. A supplementary 
questionnaire, the Pittsburgh Sleep Quality Index (PSQI), will be given to participants to obtain 
information on their quality of sleep. 
 
Self-reported outcomes 
In order to evaluate overall patient health status and health-related quality of life, they will be asked 
to complete self-reported questionnaires that measure: physical activity (Duke Activity Status 
Index; DASI),  quality of life (EQ5D), the Hospital Anxiety and Depression Scale (HADS(20)), 
distress thermometer, the WHO Disability Assessment Schedule v2.0 (WHODAS), and the energy 
expenditure (CHAMPS)(21,22).  
 
Surgical outcomes 
Surgical outcomes information will be taken for patients’ medical files. Postoperative 
complications will be recorded and scored using the Clavien-Dindo Classifications(CDC) and the 
comprehensive complication index (CCI) (23). 30-day mortality will assess the number of deaths 
within the first 30 days post-surgery. Length of intensive care stay will be assessed as the number 
of hours from arrival to the unit. Days with a chest tube will be assessed as the number of days and 
hours for the last day, if applicable. Length of Hospital Stay will be assessed as a number of post-
operative hours until discharge. 
 
Potential confounding variables  
The current study will investigate a diverse patient population. A large degree of variability is to 
be expected in the observed functional and clinical outcomes. Several factors are known to affect 
patient prognosis and recovery, among them baseline BMI, smoking status, comorbidities (CCI), 
type of cancer, neoadjuvant therapies (type and duration) and duration of the prehabilitation 
program. Therefore, the current study will investigate the impact each factor on the reported 
outcomes. 
Data analysis plan 
All measures will be recorded at baseline (beginning of prehabilitation period; T0), within the 24 
hours prior to surgery (end of prehabilitation period; T1) and further at 4- (T2) and 8-weeks (T3) 
follow-ups after surgery.  
 

 
 
8 
Descriptive analyses will be used to compare demographics, and baseline functional and 
pathological state. Mean and standard deviations will be reported when data is normally distributed, 
as parametric analyses will be selected 
 
To assess feasibility, the recruitment, completion and adherence rates were computed. A one-
sample one-sided z-test test will be performed on the adherence rate of participants with a set 
threshold of 71%, based on the internal historical data.  
 
The change in functional outcomes, nutritional status, and self-reported outcomes parameters will 
be analyzed using paired z-test comparing means from pre- (T0) and post-tests (T1, T2 & T3). 
Addition analyses will include achieving the 80% adherence rate and dichotomous surgical, 
functional, nutritional, and self-reported variables (presented as percentages) to be compared using 
chi-square (or Fisher exact) testing. 
 
To appraise the strengths of correlation at the different time points throughout the observation 
period, robust repeated measures modeling with linear mixed models will be applied, which 
accounts for the repeated nature of the continuous measurements (ANOVA).  
 
These calculations will be performed using the PASW Statistics software version 24.0, with 
confidence interval and significance level preset at 95% and 0.05, respectively. (SPSS Inc, Chicago, 
Illinois).  
 
Details on confidentiality 
Confidentiality 
The technologies used in this project, e.g. Zoom videoconferencing and Polar watch 
applications, use confidential information (email, name), patients will receive the material 
(tablet and watch) with already pre-set accounts from the IT department of the MUHC, 
coding their identity fully (where both name and email will be coded). Patients will be 
encouraged to read the Privacy Notices for both Polar and Zoom applications. Further, the 
Polar Ignite watch has a GPS which records location and distances travelled when activated 
during cardiopulmonary trainings sessions. This information will be disclosed to patients, as 
it may play a role in patients’ willingness to participate. 
 
Data Collection, Storage & Security, Handling and Record Keeping 
The research coordinator (Bhagya Tahasildar, MD.) and PI (Francesco Carli) will assign identifiers 
to each study participant. These identification numbers (ID: PPP1 to PPP100) will not contain any 
Protected Health Information (PHI) (e.g., social security number, medical records number, etc.).  
The information collected for the purpose of the research study will be kept strictly confidential 
and locked in a cupboard within a locked room in the Prehabilitation Clinic at MGH. All staff, 
including students, have signed a confidentiality agreement. The password-protected computer 
where data is entered is located in a locked room and not accessible to patients and external 
members of the hospital.  
 
Since the tablets will be provided with an internet data and connection, the cookies will be disabled 
by the IT department of the MUHC. Additionally, patients will be asked to close their internet 
browser after each counselling appointment in order to maximize privacy and data protections.  
All information (demographic, clinical, patient-reported questionnaires and adherence data) will be 
entered and managed in Redcap, a secure clinical trials management system. Data will be stripped 
of any identifying information (name, address) and each subject will be assigned a study number. 
All of the information obtained will be treated in a confidential manner.  
 

 
 
9 
Study investigators, approved staff, collaborators and local IRB  will have access to review records 
for research, quality assurance, and data analysis. 
Data collected before the moment where participants express their wish to stop participating, or 
where participants are lost in follow-up can be analyzed in a confidential manner, unless otherwise 
specified by the participants.  
 
Following closure of the study, the principal investigator will maintain all study records in a safe 
and secure location for seven years, as specified by local regulations. The records will be accessible 
to allow for appropriate audit and investigations. 
Statement on ethical considerations 
The study will be submitted to the McGill University Health Centre Ethics Board for 
approval. Three studies on prehabilitation (see Background, above) were approved and completed 
by our team in our institution (McGill University Health Centre-Montreal General Hospital 
Research Ethics Committee REC#02-053, #09-284). 
 
Other support 
Our group has received a research grant from the MGH foundation and the Peri-Operative Program 
(POP) Foundation to support this project.  
 
Registration  
The proposal will be registered for Clinical Trials.  
 
 

 
 
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