Trimodal Prehabilitation in Colorectal Cancer Patients

Study Overview
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Brief Summary
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The goal of this clinical pilot is to determine the feasibility of implementing trimodal prehabilitation within the current perioperative infrastructure in patients having major colorectal surgery for resection of a cancer (CRC). Trimodal prehabilitation includes exercise, nutrition and mindfulness coaching and support which has been shown to improve physical status, mental preparation and to reduce loss of lean body mass in CRC patients. The primary questions this study aims to answer are: Is delivery of trimodal prehabilitation feasible within our current perioperative infrastructure and does prehabilitation impact outcomes in these patients? Researchers will compare this newly recruited prehabilitation cohort to a historical cohort of patients who did not receive prehabilitation in terms of mortality, length of stay, complications, readmissions, emergency department visits and non-home discharge.

Detailed Description
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Fifty patients aged 18 years or greater booked to undergo major colorectal surgery (colectomy, low anterior resection or abdominoperineal resection) will be enrolled from June to August 2023 from the colorectal cancer (CRC) clinic at Kingston Health Sciences Centre in Kingston, Ontario. The CRC nurse navigator will identify new CRC diagnoses coming into clinic and will alert the research team. A research assistant will attend the CRC clinic when potentially eligible patients are booked and will approach regarding recruitment into the study. Exclusion criteria will include refusal to participate in study and inability to understand questionnaires and participate in psychological assessments in English. Once recruited to study, the research assistant will give the patient the prehabilitation resources (including a prescription for aerobic and strength exercises to be completed each week, 36 Premier Protein shakes (30g protein, 150 calories per shake) and a handout describing deep breathing exercises) and arrange a time with the patient to complete baseline questionnaires and deliver prehabilitation consultation. The rationale for delaying this initial consultation is to prevent overwhelming patients with information after receiving a new cancer diagnosis. Patients will have a prehabilitation study consultation including completion of three questionnaires: self-assessment of physical activity (CHAMPS), nutritional screening (CNST) and health care related quality of life (SF-36). Patients will then be given all prehabilitation education and counselling. Study patients will participate in a trimodal prehabilitation program (including exercise, nutrition and mindfulness goals) prior to surgery, and will be randomized into two groups: 1) Prehabilitation with twice-weekly progress checks (adherence to prehabilitation program) and 2) Prehabilitation without progress checks. Both groups of patients will complete daily activity trackers to document exercise completion, protein drink consumption and deep breathing exercises. One week prior to surgery, a research assistant will contact all participants and conduct CHAMPS, CNST and SF-36 as well as collect feasibility outcomes including weeks available for prehabilitation before surgery, satisfaction with prehabilitation program and adherence to program (participating in phone calls, completing exercises, daily protein shake (30g) and mindfulness exercise). Groups that are designated as including progress checks will be called by a research assistant twice per week to check in on progress regarding all components of prehabilitation program (adherence, compliance, issues). An additional analysis will be performed comparing the 50 patients from this feasibility pilot (prehabilitation group) to the previous 50 patients booked for major colorectal surgery (standard care group) using existing data from the colorectal database. These groups will be assessed for secondary outcomes including mortality, length of stay, emergency department visits, readmissions, major complications and non-home discharge. This pilot study will guide the development of a larger study to assess the delivery of prehabilitation and rehabilitation after major colorectal surgery utilizing CloudDX, software that can be programmed to deliver reminders, surveys and important information to assist with adherence to the prehabilitation regimen. In addition, these future studies will utilize remote vital sign monitoring via CloudDX to collect important biometric data to richen the interpretation of the effects of prehabilitation on this patient population.

Official Title
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Trimodal Prehabilitation in Colorectal Cancer Patients: a Feasibility Pilot

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Behavioral: Exercise
* Dietary Supplement: Nutrition
* Behavioral: Mindfulness


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 or older major colorectal surgery (colectomy, low anterior resection or abdominoperineal resection) Exclusion Criteria: refusal to participate in study inability to understand questionnaires and participate in psychological assessments in English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Progress Check<br>This arm will include pre- and post-prehabilitation questionnaires as well as twice weekly progress checks by the research assistant to check on participant progress, answer questions and provide accountability and motivation. | Behavioral: Exercise<br>* Aerobic and Strength exercises (equipment free, simple, modifiable)<br>Dietary Supplement: Nutrition<br>* Counselling on daily protein target of 1.2 g/kg as well as supplementation with protein shake (provided)<br>Behavioral: Mindfulness<br>* Deep (box) breathing completing in the morning, evening and as needed.<br>|
| Other: No Progress Check<br>This arm will include only pre- and post-prehabilitation questionnaires. | Behavioral: Exercise<br>* Aerobic and Strength exercises (equipment free, simple, modifiable)<br>Dietary Supplement: Nutrition<br>* Counselling on daily protein target of 1.2 g/kg as well as supplementation with protein shake (provided)<br>Behavioral: Mindfulness<br>* Deep (box) breathing completing in the morning, evening and as needed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention rate | Rate of participants who completed entire duration of prehabilitation, regardless of components performed | Four to six weeks prior to surgery | 
| Recruitment rate | Number of patients booked for surgery compared to the number of overall patients booked for surgery during the study timeframe. | Four to six weeks prior to surgery | 
| Exercise completion rate | Percentage of strength exercises completed and percentage of aerobic exercise completed | Four to six weeks prior to surgery | 
| Nutrition compliance rate | Percentage of days protein shake was consumed | Four to six weeks prior to surgery | 
| Mindfulness compliance rate | Percentage of deep breathing exercises performed | Four to six weeks prior to surgery | 
| Adherence rate | Percentage of all components of prehabilitation completed by participants | Four to six weeks prior to surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause Mortality | Number of participants who died from any cause | 30 days after surgery | 
| Readmission to hospital | Number of participants who were re-admitted to hospital | 30 days after surgery | 
| Presentation to emergency department | Number of participants who presented to the emergency department | 30 days after surgery | 
| Non-home discharge | Number of participants discharged to a non-home location | 30 days after surgery | 
| Major complications | Rate of surgical site infection and major bleeding | 30 days after surgery |