Clinical trial NCT05880992: Trimodal Prehabilitation in Colorectal Cancer Patients
Official title: Trimodal Prehabilitation in Colorectal Cancer Patients: a Feasibility Pilot
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

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

Primary outcomes:
measure: Retention rate
timeFrame: Four to six weeks prior to surgery
measure: Recruitment rate
timeFrame: Four to six weeks prior to surgery
measure: Exercise completion rate
timeFrame: Four to six weeks prior to surgery
measure: Nutrition compliance rate
timeFrame: Four to six weeks prior to surgery
measure: Mindfulness compliance rate
timeFrame: Four to six weeks prior to surgery
measure: Adherence rate
timeFrame: Four to six weeks prior to surgery
Secondary outcomes:
measure: All-cause Mortality
timeFrame: 30 days after surgery
measure: Readmission to hospital
timeFrame: 30 days after surgery
measure: Presentation to emergency department
timeFrame: 30 days after surgery
measure: Non-home discharge
timeFrame: 30 days after surgery
measure: Major complications
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
Study officials:
affiliation: Queen's University
name: Jordan Leitch
role: PRINCIPAL_INVESTIGATOR
References:
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