Trimodal Prehabilitation in Colorectal Cancer Patients

Trial Title: Trimodal Prehabilitation in Colorectal Cancer Patients

NCT ID: NCT05880992

Condition: Colorectal Cancer

Conditions: Official terms:
Colorectal Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Exercise
Description: Aerobic and Strength exercises (equipment free, simple, modifiable)
Arm group label: No Progress Check
Arm group label: Progress Check

Intervention type: Dietary Supplement
Intervention name: Nutrition
Description: Counselling on daily protein target of 1.2 g/kg as well as supplementation with protein shake (provided)
Arm group label: No Progress Check
Arm group label: Progress Check

Intervention type: Behavioral
Intervention name: Mindfulness
Description: Deep (box) breathing completing in the morning, evening and as needed.
Arm group label: No Progress Check
Arm group label: Progress Check

Summary: 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: 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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Kingston Health Sciences Centre

Address:
City: Kingston
Zip: K0H1S0
Country: Canada

Status: Recruiting

Contact:
Last name: Jordan Leitch

Phone: 6134494223
Email: jordleitch@hotmail.com

Start date: July 24, 2023

Completion date: June 30, 2025

Lead sponsor:
Agency: Jordan Leitch
Agency class: Other

Source: Queen's University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05880992