Implementation of a Prehabilitation Pilot Program for Individuals With Frailty Undergoing Oncologic Surgery
Phase: NA
Conditions: Prehabilitation, Oncology, Surgical Oncology
Sponsor: MaineHealth

 
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Implementation of a Prehabilitation Pilot Program for Individuals with Frailty 
Undergoing Oncologic Surgery 
2/15/22 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Principal Investigator:  
 
 
Timothy Fitzgerald, MD 
 
 
 
 
 
 
Surgical Oncologist, Director of Surgical 
 
 
 
 
 
 
Oncology 
 
 
 
 
 
 
Maine Medical Center 
 
 
 
 
 
 
Portland, Maine 
 
Co-Investigators:   
 
 
 
 
Amy Litterini, PT, DPT 
Program Manager, Survivorship 
MaineHealth Cancer Care Network 
Scarborough, Maine 
 
Laura Nicolais, MD 
General Surgery Resident 
Maine Medical Center 
Portland, Maine 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
BACKGROUND 
As the population ages, older, frailer people represent a larger portion of the patients surgeons 
treat.1 Although there is currently no agreed upon definition of frailty, it is commonly accepted 
that frail is a state of increased vulnerability to stressors due to decreased physiologic reserve.2,3 
Frail individuals are at increased risk for falls, disability, long term care, and death.2  Surgery is a 
major stressor, to which frail individuals can be particularly vulnerable. Frailer surgical patients 
incur more health costs, have increased rates of mortality, experience more postoperative 
complications, and are more likely to have loss of independence.4-7 
 
Frailty is commonly accepted as a construct capturing a group of factors that predict medical 
outcomes. In existing studies, pre-operative frailty screening tools inclusive of these factors have 
been shown to effectively predict surgical patients who are at increased risk for poor 
outcomes.4,7,8  One proposed score is the Risk Analysis Index (RAI). The RAI was created as a 
rapid and cost-effective way to pre-operatively evaluate frailty in elective surgical patients.9 
Maine Medical Center (MMC) has recently implemented the RAI in multiple surgical clinics. To 
this point, MMC has only screened patients but has not yet been able to implement interventions 
based on a patient’s status as frail.   
 

 
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Prehabilitation has been suggested as a way to improve outcomes for frail surgical patients. 
Prehabilitation is a multimodal preoperative approach to enhance patient condition, and aims to 
decrease rates of postoperative complications, hasten recovery, and improve overall quality of 
life. Prehabilitation applies methods such as improved nutrition and exercise programs to 
increase the physiologic reserve of a patient planned to undergo surgical intervention.10  Some 
studies have suggested improved physiologic gains11-13 and reduced rates of complications14,15 
after implementation of these programs. Current perioperative recovery pathways, in multiple 
surgical pathways, recommend routine use of prehabilitation programs.16-18 
 
Recent efforts at MMC have used the Delphi Method to identify the ideal exercise-based 
prehabilitation program. Through this method, seven academic physical therapists participated in 
a series of three questionnaires. They came to the consensus that the prehabilitation program 
should focus on light cardiovascular exercise, strength training, and functional training.  Further, 
they determined the cardiovascular training should occur for a total duration of 30-minutes daily. 
Additionally for strength and functional training, patients should start each exercise with 1 set of 
10 repetitions, increasing to a maximum of 3 sets of 15 repetitions. The initial intensity was 
recommended to be 3-5/10 (moderate to hard) on the Borg Rating of Perceived Exertion (RPE) 
Scale and maximum intensity of 6-7/10 (RPE [hard to really hard]).19  
 
We now hope to implement this prehabilitation program in the clinics at Maine Medical Center. 
Our long term goal is the introduce this program in all surgical specialties; but first, we plan to 
assess adherence, patient self-efficacy, frailty and health-related quality of life through a pilot 
study in the surgical oncology clinic.  
 
In summary, frailty is a state of increased vulnerability to stressors with increased rates of poor 
outcomes. Surgery is one of these stressors, and previous research has therefore shown increased 
rates of morbidity and mortality in frail patients undergoing surgery. Prehabilitation programs 
can help mitigate the negative outcomes associated with frailty. We hope to implement a newly 
developed prehabilitation pilot program in the MMC Surgical Oncology Clinic to initially 
evaluate adherence, self-efficacy, and health-related quality of life. 
HYPOTHESIS 
Implementation of a prehabilitation program will be feasible and will improve clinical status.  
SPECIFIC AIMS 
We propose to pilot (N=20) and assess a new prehabilitation program for frail surgical oncology 
patients. We will: 
1. Assess feasibility. We will: 
a. Evaluate adherence through analysis of patient maintained exercise logs.  
b. Assess self-efficacy by evaluating the relationship between pre-program self-
efficacy score and adherence.  
c. Assess patient satisfaction and barriers to adherence through a post prehab 
program survey. 

 
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2. Assess clinical impact. We will: 
a. Evaluate health-related quality of life before and after participation in the 
prehabilitation program. 
b. Evaluate frailty before and after participation in the prehabilitation program. 
METHODS 
Study Design: Prospective cohort study 
This longitudinal study will be a prospective, non-randomized, within-subject design focused on 
patients diagnosed with complex gastrointestinal (GI) cancer evaluated and treated at Maine 
Medical Center by the Surgical Oncology Service. All subjects who meet the inclusion criteria 
will be offered the opportunity to be enrolled; these recruitment efforts will cease when planned 
enrollment is complete. Participants will complete a prehabilitation exercise program through the 
Thinkific platform. Data on frailty, quality of life, self-efficacy and adherence will be collected 
through surveys and patient maintained exercise logs.  
 
Study Population 
Participants will be selected from the population of patients at the MMC Surgical Oncology 
Clinic. Patients at this clinic are being evaluated for surgical treatment of oncologic diseases 
such as colorectal or pancreatic cancer. Under normal circumstances, patients are seen for an 
initial consultation where a treatment plan is created. Patients either have surgery or 
chemotherapy up front. If the patient has surgery as the first treatment, the surgery is scheduled 
at that initial appointment. If the patient has chemotherapy before surgery, they will return for at 
least one more appointment after completion of chemotherapy. Their surgery is scheduled at this 
follow-up appointment. This process can span anywhere from 4 weeks to 6 months.  
 
Yearly, this clinic evaluates 181 and 143 patients with colorectal and pancreatic cancer, 
respectively. Part of the goal of this study is to evaluate feasibility as well as adherence and thus, 
patient tolerance of the prehabilitation program. Therefore, we propose to enroll 20 patients from 
this population, knowing that there may be some attrition. Participants will meet the following 
criteria: 
 
Inclusion Criteria-  
a) Subjects ≥18 years old 
b) Evaluated at MMC by surgical oncology service 
c) Planned surgical intervention for gastrointestinal oncologic condition  
d) Score ≥40 on RAI frailty screening 
e) Physically able to participate in prehabilitation exercises 
f) Home internet access and established email account 
g) Able to speak and read he English language 
Exclusion Criteria-  
a) Patients unable to participate in exercises included in prehabilitation program  
b) Patients with impaired decision making capacity as determined by the treating physician  
c) Those in a high risk community: prisoners and pregnant women 

 
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d) Those who are visually impaired and unable to complete the course independently 
e) Those who do not meet the above inclusion criteria  
Recruitment: 
Patients are screened by nursing staff for frailty at each routine clinic visit using the RAI survey 
as part of their standard care. By reviewing the final RAI score obtained during the initial visit to 
the Surgical Oncology Clinic, the attending surgeon (see key personnel form) will know 
clinically if the patient is considered frail and therefore if he/she is eligible for inclusion in the 
research study. The attending surgeon will not need to go back to review the RAI score in-depth 
for research purposes. In addition to the RAI score, the attending surgeon will use 
inclusion/exclusion criteria to evaluate each patient’s eligibility for this pilot study. If the patient 
meets these criteria, the attending surgeon will give the patient a recruitment flyer (see attached) 
during the same visit to introduce the study requirements, expectations and possible benefits.  
The attending will answer any questions the patients may have at that time.  No other 
recruitment, including active recruitment, will occur.  
 
Informed Consent Process  
Once the patient has read the study flyer and has been given the opportunity to have questions 
answered by the attending surgeon, the physician will establish their interest in participation. If 
interested they will be given a copy of the informed consent form (please see attached) and the 
physician will talk through this form with them, again, answering any questions they may have. 
The discussion of consent will contain information on: the purposes, procedures, and duration of 
the research; any reasonably foreseeable risks and benefits of the research; and how 
confidentiality will be maintained.  Patients who agree to participate and sign the informed 
consent form will be considered enrolled in the study. The participant will be given a copy of the 
signed consent form and the original version will be maintained in study records. 
 
 
Study Procedures 
 
If patients choose to participate and subsequently provide informed consent, they will create a 
password protected account to the Thinkific Prehabilitation Exercise Program during this initial 
clinic visit. The study team will provide the participant with an instruction sheet (see attached) 
with the Thinkific URL to guide the creation of the account on a device in the clinic exam room.  
Thinkific is an online platform that Maine Medical Center utilizes for patient education. Please 
refer to the link below to access the specific Thinkific course that will be used in this study.  This 
course was created through collaboration with the MaineHealth Education and Training 
Department and was based on Thinkific courses created for patients at MMC for other surgical 
specialties such as orthopedic and transplant surgery. Please see the attached screen shot of the 
Thinkific course welcome page. This page will further inform participants about the course 
layout and expectations.  

 
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After the account is created, participants will complete two electronic baseline surveys on an in 
room device during this initial clinic visit: the 36-Item Short Form Survey (SF-36) and the Self-
Efficacy for Home Exercise Programs Scale (SEHEPS). The link for these REDCap surveys will 
be imbedded in Thinkific.  A study team member will be available to assist in creation of the 
Thinkific account or completion of these initial surveys. Participants will leave their initial clinic 
appointment with a packet containing: a 3 pack of resistance bands, a copy of their consent form 
and a copy of the informational packet about the exercise program (see attached) that can 
otherwise be accessed through the Thinkific course.  
 
Participants will additionally access the Thinkific account at home to complete an exercise based 
prehabilitation course. This course will provide video and written instruction on how to perform 
each exercise safely, as well as how to properly increase the intensity of the program, (e.g. 
resistance, number of repetitions and sets). This program will also include links to the American 
College of Surgeons alcohol related recommendations and the Maine QuitLink for 
tobacco/smoking and vaping cessation that patients may access if applicable. Participants will be 
instructed to perform daily exercise and keep track of their exercise in either a handwritten or 
electronic log (see attached document) until their surgery or until the final clinic visit if surgery 
is ultimately not performed. The log is available as a paper copy provided at the first visit and as 
a pdf embedded in the Thinkific course.  
 
 https://mainehealth.thinkific.com/courses/prehab-exercise 
 
Repeat self-administered survey with the SF-36 will become available through a direct email link 
from REDCap at two and four weeks after initiation of the prehabilitation program. If 
participants do not complete the surveys, they will receive a reminder email, generated 
automatically by REDCap, at 24 and 48hrs after the initial email was sent (please see attached 
screen shot of emails). At the final clinic visit prior to surgery, the participant’s exercise log will 
be collected by the study team. The participant’s exercise log will either be physically brought to 
clinic or uploaded by the participant through the Thinkific platform prior to this final 
appointment. Repeat frailty screening, with the RAI, will be performed by the surgical oncology 
clinic nursing staff at every follow up clinic appointment until surgery as part of the patients’ 
normal care.  
 
Participants will complete a final self-administered SF-36 survey and a survey to assess their 
satisfaction with the exercise prehabilitation program anytime during the week leading up to 
their surgery, or the week after their final appointment if they ultimately are not a surgical 
candidate.  The link to this final REDCap survey is embedded in Thinkific. The surgeon will 
remind patients at their final clinic visit to complete these surveys. 
 
During the extent of the study, if patients have questions pertaining to the study they will be able 
to contact their surgeon at any time by contacting the surgical oncology clinic. If the patient has 
questions or concerns related to the performance of the prehabilitation program exercises, they 
will be directed to a licensed physical therapist.  
 
Please reference to the attached material to view each of the following surveys: 

 
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Risk Analysis Index (RAI): 
The RAI is a validated frailty screening tool that was developed and implemented at the 
University of Nebraska. Components of the RAI include nursing home admission, unintentional 
weight loss, renal failure, congestive heart failure, poor appetite, gender, shortness of breath, 
malignancy, age, cognition, and activities of daily living.20  
 
36-Item Short Form Survey (SF-36): 
SF-36 is a well-researched, self-reported measure of health which stems from the Medical 
Outcomes Study. It comprises 36 questions which cover eight domains of health: 
Limitations in physical, social or usual role activities due to physical or mental health 
problems, bodily pain, general mental health (psychological distress and well-being), 
vitality (energy and fatigue), and general health perceptions. This measure is now widely 
utilized by managed care organizations and by Medicare for routine monitoring and assessment 
of care outcomes in adult patients.21  
 
Self-Efficacy for Home Exercise Programs Scale (SEHEPS): 
The SEHEPS is a clinically useful tool to evaluate patients’ self-efficacy in home-based 
musculoskeletal exercise programs. It is a 12-item patient-reported questionnaire on which 
patients rate their confidence in performing home-based exercise on a 7-point scale.22  
 
Satisfaction Survey: 
This survey was developed in house by the study team because an appropriate validated tool 
could not be found in the literature. It will utilize a Likert-type rating scale to assess participant 
satisfaction with the Thinkific platform and the video/handout instructions. Additionally, it will 
evaluate the participants’ perceived mental and physical benefit from the program. See attached 
survey.  
DATA COLLECTION, MANAGEMENT, AND ANALYSIS 
 
Data Collection 
Data pertaining to the patient demographics and baseline characteristics will be collected by the 
study team through manual extraction from Epic. Data from the participants exercise logs will be 
manually extracted by the study team from either the Thinkific platform or Epic depending on 
how the participant submitted this form (i.e. electronically on Thinkific or manually bringing the 
log to their appointment for uploading to Epic by the study staff). The surveys will be completed 
electronically in the office setting on the exam room computer or online at home through 
REDCap (via emailed link or a link to REDCap embedded in Thinkific). These data will 
automatically upload to REDCap. Please refer to the master list and data collection document 
submitted with this proposal for a list of variables that will be collected.  
 
 
Date Management 
All data will be collected and maintained in a REDCap database to which only the study team 
will have password protected login access. The data collected through manual extraction from 
EPIC will be entered into REDCap by members of the study team. Data from the RAI surveys 

 
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performed as part of routine care will be initially recorded in Epic then manually transferred into 
REDCap.  
 
Data from the SF-36, SEHEPS and satisfaction survey will be directly submitted into REDCap 
from either an emailed link or link embedded in Thinkific. Once uploaded, the participants 
formula ID (first two letters of first name + first two letters of last name) and email, will help us 
manually link the survey entry to the master list and the second survey data collection form.  Of 
note, the participant will only enter their email and formula ID at the beginning of the first and 
last surveys. The email entry is necessary to send out the 2 week and 4 week surveys. The email 
will also serve as a second patient identifier if participants have identical formula IDs. When 
more than one survey is completed on the same day, the separate surveys are linked together 
through REDCap. This means the participants only need to type their formula ID and email once, 
despite completing multiple surveys. (please see the attached email chain and document from 
Deanna regarding REDCap security and her support for this plan) 
 
The exercise logs will be reviewed by the study team in Thinkific or through Epic, if the 
participant brought a paper log, then entered into REDCap. If participants bring a paper form of 
their exercise log, it will be scanned into their EPIC account by a member of the study team and 
the paper copy of the exercise log will be shredded after the image has been uploaded into Epic.  
The signed consent form will be secured in a locked file cabinet behind a locked office door in 
the Surgical Oncology Department at 887 Congress Street.  
 
A master list will be maintained in REDCap separate from other study documents. Only a study 
ID, consisting of the first 2 letters of the first and last name, will link this master list to the  two 
data collection files on REDCap. Once the data collection is finalized, the master list will be 
deleted. The limited data set that remains will then be exported as a CSV file that will be 
maintained as an encrypted file on a password protected MMC institution desktop.  This limited 
dataset will be accessed only from MMC computers and only by MMC study team listed above 
and by members of the IRB if needed.   
 
All regulatory documents and files associated with the study (IRB documents, HIPAA-related 
documentation) will be maintained for a minimum of 6 years after the final publication/report 
and then deleted/destroyed.   
 
Data Analysis 
Statistical analysis will be completed by the research fellow with support from CORE or 
statisticians. Data will be summarized using standard descriptive statistics. Continuous data will 
be shown as mean (standard deviation) or median [range], as appropriate, and categorical data 
will be shown as frequency (n, %). Paired analyses will be performed using the McNemar test 
for categorical data and the paired t test or Wilcoxon signed rank test for continuous data, as 
appropriate. Changes in survey scores over time will be assessed with repeated measures 
ANOVA or mixed models regression, as appropriate. Relationships among variables will be 
assessed by linear regression. “R” software will be used for data manipulation and all statistical 
analysis. As this is a pilot study, the parameters needed to support power analysis were not 
available. Therefore all statistical comparisons and relationships will be considered exploratory 

 
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with no anticipation of statistical significance. Statistical significance will be accepted at p < 
0.05.  
ANTICIPATED RISKS AND BENEFITS 
The risks involved with participation in this study are low. One possible risk is for temporary 
muscular soreness. This is a risk for anyone starting a new exercise program. For those who 
experience it, the soreness is usually mild and can last for 24-72 hours following initial exercise 
sessions. Once the muscles become use to the new exercises, the soreness goes away. Further, 
participants will be able to contact a health care professional and a licensed physical therapist at 
any time during the study if they have questions or concerns. The program was explicitly 
designed for patient autonomy and independent use which is why the Thinkific instructions are 
very clear to guide the participant through every step. Despite this, patients are encourages to call 
with any questions. The number of phone calls will be tracked to assess the ideal program set up 
if implemented more widely in the future. Another risk is for loss of confidentially. Many 
safeguards are in place to ensure that the data is protected including: use of REDCap for storage 
of the master list, password protection on the desktop of the PI and co-investigators, anti-virus 
software on desktops, and avoidance of use of mobile devices for storing data.  
 
We believe that most individuals will benefit by participating in this study. Participants are likely 
to see improvements in strength and endurance to participation in a regular exercise program. 
Further, these improvements may help participants recovery from surgery. This pilot study 
would be the first step towards offering surgical patients what is becoming standard of care. The 
data collected will be used to benefit patients in the future. If the results of this pilot study 
support our hypothesis, it is likely the prehabilitation program will be implemented widely for 
surgical patients at MMC. This holds the potential for a large positive impact in the future by 
reducing negative post-surgical outcomes. This likely has the benefit of not only improved 
quality of life and functionality for the patient, but also decreased healthcare utilization and cost.   
POTENTIAL PROBLEMS 
• Loss to follow up: As a prospective study, patients enrolled may be loss to follow up. 
Some reasons include if a patient transitions care to a different provider or moves. The 
study team will make efforts to maintain all participant and will perform phone calls if 
needed to re-engage participants that may have been lost. (please see phone script) 
• Technology: One of the inclusion criteria for this study is home internet access and 
established email account. Having these does not mean a participant will be proficient in 
using the internet. They may struggle to access or use the technology. To try and combat 
this, we have made care members easily available to answer questions and help 
participants trouble shoot. 
TIMELINE 
Because this intervention is recommended in most perioperative protocols, we hope to 
implement this program as soon as possible. Our goal is to recruit 20 patients within three 
months. Each patient will participate in the prehabilitation program for at least two weeks. It is 

 
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difficult to predict how long a patient will be in the program because the duration depends on 
when their surgery is eventually scheduled. This is individualized, and typically ranges from two 
weeks to six months. We hope to complete data collection in seven months. At that time, we 
hope to complete data analysis and submit an abstract by July, 2022. 
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